Ebi L L C

FDA Filings

This page includes the latest FDA filings for Ebi L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003435252
• FEI Number: 3003435252
• Name: EBI PATIENT CARE, INC.
• Owner & Operator: EBI, LLC
• Contact Address: 399 Jefferson Road --; Parsippany NJ 07054 US
• Official Correspondent:
  • Robert W Kokowitz
  • x-973-2999300-2156
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 484 Calle E ; GUAYNABO, PR 00969 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 2242816
• FEI Number: 2242816
• Name: EBI, LLC
• Owner & Operator: EBI, LLC
• Contact Address: 399 Jefferson Road --; Parsippany NJ 07054 US
• Official Correspondent:
  • Robert W Kokowitz
  • x-973-2999300-2156
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 399 Jefferson Rd ; PARSIPPANY, NJ 07054 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P850035S056 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2021-02-17
PMA P790005S067 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2021-02-17
PMA P850022S030 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys	2019-12-03
PMA P850035S055 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2019-07-18
PMA P790005S066 EBI, LLC	OsteoGen Surigically Implantable Bone Growth Stimulators	2019-07-18
GUDID 00887868269318 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-72	2019-03-11
GUDID 00887868269301 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-63	2019-03-11
GUDID 00887868269295 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718-45	2019-03-11
GUDID 00887868269288 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-72	2019-03-11
GUDID 00887868269271 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-63	2019-03-11
GUDID 00887868269264 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716-45	2019-03-11
PMA P850035S051 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-11-02
PMA P790005S062 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-11-02
GUDID 00880304820852 EBI, LLC	Biomet SpinalPak / OrthoPak 106130-22	2018-07-06
GUDID 00880304820845 EBI, LLC	Biomet SpinalPak / OrthoPak 106130-14	2018-07-06
GUDID 00812301020676 EBI, LLC	Biomet EBI Bone Healing System 1068339	2018-07-06
GUDID 00812301020669 EBI, LLC	Biomet Bone Healing System 1068317	2018-07-06
GUDID 00812301020652 EBI, LLC	Biomet EBI Bone Healing System 1068315	2018-07-06
GUDID 00812301020645 EBI, LLC	Biomet EBI Bone Healing System 1068314	2018-07-06
GUDID 00812301020638 EBI, LLC	Biomet EBI Bone Healing System 1068313	2018-07-06
GUDID 00812301020621 EBI, LLC	Biomet EBI Bone Healing System 1068240	2018-07-06
GUDID 00812301020614 EBI, LLC	Biomet EBI Bone Healing System 1068239	2018-07-06
GUDID 00812301020607 EBI, LLC	Biomet EBI Bone Healing System 1068238	2018-07-06
GUDID 00812301020591 EBI, LLC	Biomet EBI Bone Healing System 1068237	2018-07-06
GUDID 00812301020584 EBI, LLC	Biomet EBI Bone Healing System 1068236	2018-07-06
GUDID 00812301020577 EBI, LLC	Biomet EBI Bone Healing System 1068235	2018-07-06
GUDID 00812301020560 EBI, LLC	Biomet EBI Bone Healing System 1068234	2018-07-06
GUDID 00812301020553 EBI, LLC	Biomet EBI Bone Healing System 1068233	2018-07-06
GUDID 00812301020546 EBI, LLC	Biomet EBI Bone Healing System 1068229	2018-07-06
GUDID 00812301020539 EBI, LLC	Biomet EBI Bone Healing System 1068228	2018-07-06
GUDID 00812301020522 EBI, LLC	Biomet EBI Bone Healing System 1068227	2018-07-06
GUDID 00812301020515 EBI, LLC	Biomet EBI Bone Healing System 1068226	2018-07-06
GUDID 00812301020508 EBI, LLC	Biomet EBI Bone Healing System 1068225	2018-07-06
GUDID 00812301020492 EBI, LLC	Biomet EBI Bone Healing System 1068224	2018-07-06
GUDID 00812301020485 EBI, LLC	Biomet EBI Bone Healing System 1068223	2018-07-06
GUDID 00812301020478 EBI, LLC	Biomet EBI Bone Healing System 1068222	2018-07-06
GUDID 00812301020461 EBI, LLC	Biomet EBI Bone Healing System 1068215	2018-07-06
GUDID 00812301020454 EBI, LLC	Biomet EBI Bone Healing System 1068210	2018-07-06
GUDID 00812301020447 EBI, LLC	Biomet EBI Bone Healing System 1068209	2018-07-06
GUDID 00812301020430 EBI, LLC	Biomet EBI Bone Healing System 1068208	2018-07-06
GUDID 00812301020416 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067783-2	2018-07-06
GUDID 00812301020409 EBI, LLC	Biomet OrthoPak Non-invasive Stimulator 1067783-1	2018-07-06
GUDID 00812301020393 EBI, LLC	Biomet SpinalPak / OrthoPak 1067759	2018-07-06
GUDID 00812301020386 EBI, LLC	Biomet SpinalPak / OrthoPak 1067729	2018-07-06
GUDID 00812301020379 EBI, LLC	Biomet SpinalPak / OrthoPak 1067728-1	2018-07-06
GUDID 00812301020362 EBI, LLC	Biomet SpinalPak / OrthoPak 1067728	2018-07-06
GUDID 00812301020355 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067727	2018-07-06
GUDID 00812301020348 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067725	2018-07-06
GUDID 00812301020331 EBI, LLC	Biomet SpinalPak / OrthoPak 1067724-5	2018-07-06
GUDID 00812301020324 EBI, LLC	Biomet SpinalPak / OrthoPak 1067724-4	2018-07-06
GUDID 00812301020317 EBI, LLC	Biomet SpinalPak / OrthoPak 1067724-3	2018-07-06
GUDID 00812301020300 EBI, LLC	Biomet SpinalPak / OrthoPak 1067724-2	2018-07-06
GUDID 00812301020294 EBI, LLC	Biomet SpinalPak / OrthoPak 1067724-1	2018-07-06
GUDID 00812301020287 EBI, LLC	Biomet SpinalPak / OrthoPak 1067723	2018-07-06
GUDID 00812301020270 EBI, LLC	Biomet SpinalPak / OrthoPak 1067722	2018-07-06
GUDID 00812301020263 EBI, LLC	Biomet SpinalPak / OrthoPak 1067721	2018-07-06
GUDID 00812301020256 EBI, LLC	Biomet SpinalPak / OrthoPak 1067720	2018-07-06
GUDID 00812301020249 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067719	2018-07-06
GUDID 00812301020232 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System 1067718	2018-07-06
GUDID 00812301020225 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067717	2018-07-06
GUDID 00812301020218 EBI, LLC	Biomet SpinalPak Non-invasive Spine Fusion Stimulator System 1067716	2018-07-06
GUDID 00812301020201 EBI, LLC	Biomet SpinalPak / OrthoPak 106130-20	2018-07-06
GUDID 00812301020195 EBI, LLC	Biomet SpinalPak / OrthoPak 106130-17	2018-07-06
GUDID 00812301020188 EBI, LLC	Biomet SpinalPak / OrthoPak 106130-12	2018-07-06
GUDID 00812301020133 EBI, LLC	SpF®-PLUS-Mini (60 uA/W) 10-1398W	2018-07-06
GUDID 00812301020126 EBI, LLC	SpF®-PLUS-Mini (60 uA/M) 10-1398M	2018-07-06
GUDID 00812301020119 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1348S	2018-07-06
GUDID 00812301020102 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1348M	2018-07-06
GUDID 00812301020096 EBI, LLC	SpF®-XL IIb Implantable Spinal Fusion Stimulator 10-1335W	2018-07-06
GUDID 00812301020089 EBI, LLC	SpF XL IIb Implantable Spinal Fusion Stimulator 10-1335M	2018-07-06
GUDID 00812301020072 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1328S	2018-07-06
GUDID 00812301020065 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1328M	2018-07-06
GUDID 00812301020058 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1322S	2018-07-06
GUDID 00812301020041 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1322M	2018-07-06
GUDID 00812301020034 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320M	2018-07-06
GUDID 00812301020027 EBI, LLC	EBI OsteoGen™ Implantable Bone Growth Stimulator 10-1320	2018-07-06
GUDID 00812301020010 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulator 10-1318	2018-07-06
PMA P850035S053 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-05-07
PMA P790005S064 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-05-07
PMA P850035S052 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-05-04
PMA P790005S063 EBI, LLC	EBI OsteoGen Impantable Bone Growth Stimulators	2018-05-04
PMA P850035S050 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-04-26
PMA P790005S061 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-04-26
PMA P850035S048 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-03-30
PMA P850022S029 EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System	2018-03-30
PMA P790005S059 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-03-30
PMA P790002S037 EBI, LLC	Biomet EBI Bone Healing System	2018-03-30
PMA P850035S049 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-03-29
PMA P790005S060 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-03-29
GUDID 00888480588580 EBI, LLC	Reficio DBM Plus	2018-03-29
GUDID 00888480588573 EBI, LLC	Reficio DBM Plus	2018-03-29
GUDID 00888480588566 EBI, LLC	Reficio DBM Plus	2018-03-29
GUDID 00888480588559 EBI, LLC	Reficio DBM Plus	2018-03-29
GUDID 00888480588542 EBI, LLC	Reficio DBM Paste	2018-03-29
GUDID 00888480588535 EBI, LLC	Reficio DBM Paste	2018-03-29
GUDID 00888480588528 EBI, LLC	Reficio DBM Paste	2018-03-29
PMA P850035S047 EBI, LLC	SPF Implantable Spinal Fusion Stimulators	2018-03-14
PMA P850035S046 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2018-03-14
PMA P790005S058 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-03-14
PMA P790005S057 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2018-03-14
PMA P850035S045 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2017-06-02
PMA P790005S056 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2017-06-02
PMA P850035S044 EBI, LLC	SpF Implantable Spinal Fusion Stimulators	2017-03-27
PMA P790005S055 EBI, LLC	EBI OsteoGen Implantable Bone Growth Stimulators	2017-03-27
PMA P850022S028 EBI, LLC	BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM	2016-12-08
PMA P790002S036 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2016-12-08
PMA P850035S043 EBI, LLC	Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6	2016-11-17
PMA P850035S042 EBI, LLC	EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR	2016-03-18
PMA P790002S035 EBI, LLC	BIO OSTEOGEN SYSTEM 204	2016-03-07
PMA P850035S041 EBI, LLC	SPF IMPLANTABLE SPINAL FUSION STIMULATORS	2016-01-14
PMA P850022S027 EBI, LLC	BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM	2016-01-14
PMA P790005S054 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS	2016-01-14
PMA P790002S034 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2016-01-14
PMA P850035S040 EBI, LLC	SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS	2015-12-17
PMA P790005S053 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS	2015-12-17
PMA P850035S039 EBI, LLC	SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS	2015-11-06
PMA P850022S026 EBI, LLC	BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM	2015-11-06
PMA P790005S052 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS	2015-11-06
PMA P790002S033 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2015-11-06
PMA P850022S025 EBI, LLC	BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR	2015-09-09
PMA P850022S024 EBI, LLC	THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO	2015-07-15
PMN K140734 EBI, LLC	NEXTGEN ALTIUS OCT SYSTEM	2014-12-15
PMA P850035S038 EBI, LLC	SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS	2014-09-19
PMA P790005S051 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS	2014-09-19
PMA P850022S023 EBI, LLC	THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO	2014-08-28
PMA P850022S022 EBI, LLC	BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM	2014-05-09
PMA P790002S032 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2014-05-09
PMA P790002S031 EBI, LLC	BIOMET EBI BONE HEALING	2014-04-30
PMN K140123 EBI, LLC	POLARIS SPINAL SYSTEM -TRANSLATION SCREW	2014-04-24
PMA P850022S021 EBI, LLC	BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR	2014-03-26
PMA P850035S036 EBI, LLC	SPF IMPLANTABLE SPINAL FUSION STIMULATORS	2013-10-03
PMA P790005S050 EBI, LLC	EBI OSTEOGEN BONE GROWTH STIMULATORS	2013-10-03
PMA P850022S020 EBI, LLC	BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM; BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM	2013-09-12
PMA P790002S030 EBI, LLC	THE BIOMET EBI BONE HEALING SYSTEM	2013-09-12
PMA P850035S035 EBI, LLC	SPF IMPLANTABLE SPINAL FUSION STIMULATORS	2013-05-28
PMA P790005S049 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR	2013-05-28
PMA P790002S028 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2013-02-08
PMA P790002S029 EBI, LLC	BIOMET BHS-MINI	2012-12-31
PMN K113796 EBI, LLC	SOLITAIRE-C CERVICAL SPACER SYSTEM	2012-04-26
PMA P850035S034 EBI, LLC	SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)	2012-02-27
PMA P790005S048 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR	2012-01-20
PMA P790002S027 EBI, LLC	BIO OSTEOGEN SYSTEM	2011-09-07
PMA P850022S018 EBI, LLC	BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM	2011-08-11
PMN K111376 EBI, LLC	CONSTRUX EXTERNAL FIXATION DEVICE	2011-08-03
PMA P790002S026 EBI, LLC	BIOMET EBI BONE HEALING SYSTEM	2011-05-19
PMA P790005S047 EBI, LLC	ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR	2011-05-06
PMA P850022S017 EBI, LLC	ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM	2010-10-15
PMN K092670 EBI,LLC D/B/A BIOMET TRAUMA	BIODRIVE MICRO SCREW SYSTEM	2009-11-19
PMA P850035S033 EBI, LLC	SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)	2008-09-18
PMA P850035S032 EBI, LLC	EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR	2008-08-15
PMA P790005S045 EBI, LLC	EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR	2008-08-15
PMN P850035 | LOE EBI, LLC	SpF Plus-Mini (60uA/W) & SpF Plus-Mini (60uA/M)	2008-02-27
PMN P850035 | LOE EBI, LLC	SPF-Plus 60/W & SPF-Plus 60/M	2008-02-27
PMN P850035 | LOE EBI, LLC	SPF- 60 Spinal Fusion Stimulator	2008-02-27
PMN P850035 | LOE EBI, LLC	EBI SPF Implantable Spinal Fusion S	2008-02-27
PMN P850035 | LOE EBI PATIENT CARE, INC. [EBI, LLC]	SpF Plus-Mini (60uA/W) & SpF Plus-Mini (60uA/M)	2008-02-27
PMN P850035 | LOE EBI PATIENT CARE, INC. [EBI, LLC]	SPF-Plus 60/W & SPF-Plus 60/M	2008-02-27
PMN P850035 | LOE EBI PATIENT CARE, INC. [EBI, LLC]	SPF- 60 Spinal Fusion Stimulator	2008-02-27
PMN P850035 | LOE EBI PATIENT CARE, INC. [EBI, LLC]	EBI SPF Implantable Spinal Fusion S	2008-02-27
PMN P850022 | LOF EBI, LLC	SpinalPak II Bone Growth Stimulator	2008-02-27
PMN P850022 | LOF EBI, LLC	OrthoPak 2 Bone Growth Stimulator S	2008-02-27
PMN P850022 | LOF EBI, LLC	Biomet Spinalpak Non-invasive Spine Fusion Stimulator System	2008-02-27
PMN P850022 | LOF EBI, LLC	Biomet OrthoPak Non-invasive Bone Growth Stimulator System	2008-02-27
PMN P850022 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	SpinalPak II Bone Growth Stimulator	2008-02-27
PMN P850022 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	OrthoPak 2 Bone Growth Stimulator S	2008-02-27
PMN P850022 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	Biomet Spinalpak Non-invasive Spine Fusion Stimulator System	2008-02-27
PMN P850022 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	Biomet OrthoPak Non-invasive Bone Growth Stimulator System	2008-02-27
PMN P790005 | LOE EBI, LLC	EBI Osteogen Implantable Growth Sti	2008-02-27
PMN P790005 | LOE EBI PATIENT CARE, INC. [EBI, LLC]	EBI Osteogen Implantable Growth Sti	2008-02-27
PMN P790002 | LOF EBI, LLC	EBI Bone Healing System	2008-02-27
PMN P790002 | LOF EBI, LLC	EBI Bone Healing System-Model 2100	2008-02-27
PMN P790002 | LOF EBI, LLC	Biomet EBI Bone Healing System	2008-02-27
PMN P790002 | LOF EBI, LLC	Biomet BHS Mini	2008-02-27
PMN P790002 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	EBI Bone Healing System	2008-02-27
PMN P790002 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	EBI Bone Healing System-Model 2100	2008-02-27
PMN P790002 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	Biomet EBI Bone Healing System	2008-02-27
PMN P790002 | LOF EBI PATIENT CARE, INC. [EBI, LLC]	Biomet BHS Mini	2008-02-27
PMA P790002S025 EBI, LLC	BIOMET BHS- MINI	2008-01-17
PMA P850035S031 EBI, LLC	SPF PLUS 60/W AND SPF-PLUS 60/M	2007-06-21
PMA P850022S016 EBI, LLC	ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM	2006-07-27
PMA P790002S023 EBI, LLC	EBI BONE HEALING SYSTEM	2005-09-26
PMA P850035S030 EBI, LLC	EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR	2005-06-03
PMA P790005S044 EBI, LLC	EBI OSTEOGEN IMPLANTABLE GROWTH STIMULATOR	2005-06-03
PMA P850022S015 EBI, LLC	BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR	2004-01-12
PMA P850022S014 EBI, LLC	BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR	2003-05-23
PMA P850035S029 EBI, LLC	MODEL SPF-60 SPINAL FUSION STIMULATOR	2002-12-06
PMA P790002S022 EBI, LLC	EBI BONE HEALING SYSTEM - MODEL 2001	2002-08-13
PMA P850022S013 EBI, LLC	BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR	2001-10-10
PMA P850035S025 EBI, LLC	SPF IMPLANTABLE BONE GROWTH STIMULATOR	2000-09-27
PMA P850035S028 EBI, LLC	SPF SPINAL FUSION STIMULATOR	2000-06-23
PMA P790005S043 EBI, LLC	OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR	2000-06-23
PMA P790005S042 EBI, LLC	OSTEOGEN(R) D40 IMPLANTABLE BONE GROWTH STIMULATOR	2000-05-10
PMA P790002S021 EBI, LLC	EBI BONE HEALING SYSTEM-MODEL 1026	1999-12-29
PMA P850022S009 EBI, LLC	SPINALPAK(R) STIMULATOR	1999-09-24
PMA P850022S012 EBI, LLC	ORTHOPAK BONE GROWTH STIMULATOR	1999-07-26
PMA P850035S024 EBI, LLC	EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR	1999-04-07
PMA P790002S020 EBI, LLC	EBI BONE HEALING SYSTEM	1999-01-26
PMA P790002S019 EBI, LLC	EBI BONE HEALING SYSTEM(R)	1998-07-27
PMA P790005S041 EBI, LLC	EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR	1998-07-24
PMA P850022S011 EBI, LLC	ORTHOPAK II BONE GROWTH STIMULATOR	1998-07-14
PMA P850035S023 EBI, LLC	EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR	1998-05-01
PMA P790005S040 EBI, LLC	OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR	1998-05-01

Similar & Related FDA Registered Companies

• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP790005 Supplement NumberS069 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP790002 Supplement NumberS038 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS058 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850022 Supplement NumberS031 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP790005 Supplement NumberS068 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS057 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	7PER1	EBI, LLC
NCAGE Code	0AXU4	EBI, LLC!DBA BIOMET BONE HEALING TECHNOLOGIES
CAGE Code	0AXU4	EBI, LLC BIOMET BONE HEALING TECHNOLOGIES
CAGE Code	7PER1	EBI, LLC
DUNS	080329232	EBI, Llc
SEC	0001429641	EBI, LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929100933	Anvers,Belgium -> Norfolk, Virginia	CARDBOARD	16 SVN
20200929100932	Anvers,Belgium -> Norfolk, Virginia	CARDBOARD	16 SVN
20200929100930	Anvers,Belgium -> Norfolk, Virginia	CARDBOARD	16 SVN
20200929100931	Anvers,Belgium -> Norfolk, Virginia	CARDBOARD FEET	42 SVN
20200929100253	Gdynia,Poland -> Norfolk, Virginia	COMPONENTS FOR MATTRESSES PRODUCTION HS CODES 39211390, 35069900	18 PCS
20200929100125	Gdynia,Poland -> Norfolk, Virginia	COMPONENTS FOR SOFAS PRODUCTION HS CODES 940 19030, 83024200, 44119390, 44109000, 94019080	191 PCS
20200929100234	Gdynia,Poland -> Norfolk, Virginia	COMPONENTS FOR MATTRESSES PRODUCTION HS CODES 73209090, 94049090	83 PCS
20200929100178	Gdynia,Poland -> Norfolk, Virginia	COMPONENTS FOR SOFAS PRODUCTION HS CODES 940 19030, 56039390, 83024200, 44119390, 44109000	94 PCS