EBI, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2242816	2242816	EBI, LLC	1	N	2026-01-01	1 Gatehall Rd. Suite 303 PARSIPPANY NJ US 07054
3003435252	3003435252	EBI PATIENT CARE, INC.	1	Y	2026-01-01	484 Calle E GUAYNABO PR US 00969

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00812301020188	Biomet SpinalPak / OrthoPak - ELECTRODES, LT-4500	1.973.299.9300	btbs.csorders@biomet.com

biomet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
36269	1604711620	P850035	SpF® Implantable Spinal Fusion Stimulator	LOE	1987-04-30
36272	1604711620	P850035	SpF® Implantable Spinal Fusion Stimulator	LOE	1987-04-30
36269	1343828957	P850022	Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy	LOF	1986-02-18
36272	1343828957	P850022	Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy	LOF	1986-02-18
36269	1370116180	P790005	OsteoGenTM Implantable Bone Growth Stimulators	LOE	1980-01-25
36272	1370116180	P790005	OsteoGenTM Implantable Bone Growth Stimulators	LOE	1980-01-25
36269	1987108320	P790002	Biomet(R) EBI BONE Healing System	LOF	1979-11-06
36272	1987108320	P790002	Biomet(R) EBI BONE Healing System	LOF	1979-11-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LOE	4	1987-04-30
LOF	4	1986-02-18

PMA#

Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
2022-11-23
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 - Man...
SpF® Implantable Spinal Fusion Stimulators
2022-11-23
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 - Man...
Biomet® OrthoPak Non-invasive Bone Growth Stimulator System
2022-11-23
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 - Man...
EBI OsteoGen® Implantable Bone Growth Stimulators
2022-11-23
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 - Man...
SpF Implantable Spinal Fusion Stimulators
2022-08-25
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 -...
EBI OsteoGen™ Implantable Bone Growth Stimulators
2022-08-25
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 -...
EBI OsteoGen Implantable Bone Growth Stimulators
2021-02-17
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2021-02-17
EBI, LLC
Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys
2019-12-03
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2019-07-18
EBI, LLC
OsteoGen Surigically Implantable Bone Growth Stimulators
2019-07-18
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-11-02
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-11-02
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-05-07
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-05-07
EBI, LLC
EBI OsteoGen Impantable Bone Growth Stimulators
2018-05-04
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-05-04
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-04-26
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-04-26
EBI, LLC
Biomet EBI Bone Healing System
2018-03-30
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-03-30
EBI, LLC
Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System
2018-03-30
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-03-30
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-03-29
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-03-29
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-03-14
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2018-03-14
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2018-03-14
EBI, LLC
SPF Implantable Spinal Fusion Stimulators
2018-03-14
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2017-06-02
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2017-06-02
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators
2017-03-27
EBI, LLC
SpF Implantable Spinal Fusion Stimulators
2017-03-27
EBI, LLC
BIOMET EBI BONE HEALING SYSTEM
2016-12-08
EBI, LLC
BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
2016-12-08
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
EBI, LLC
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
2016-03-18
EBI, LLC
BIO OSTEOGEN SYSTEM 204
2016-03-07
EBI, LLC
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS
2016-01-14
EBI, LLC
SPF IMPLANTABLE SPINAL FUSION STIMULATORS
2016-01-14
EBI, LLC

177 records. Showing 1-40. Next

PMN#

Internal Hex Implant System
2020-01-22
EBI Inc.
Internal Octa Implant System
2017-08-31
EBI Inc.
SUITESTENSA
2017-06-23
EBIT Srl
EBI External Implant System
2015-03-27
EBI Inc
NEXTGEN ALTIUS OCT SYSTEM
2014-12-15
EBI, LLC
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
2014-04-24
EBI, LLC
SOLITAIRE-C CERVICAL SPACER SYSTEM
2012-04-26
EBI, LLC
CONSTRUX EXTERNAL FIXATION DEVICE
2011-08-03
EBI, LLC
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
2010-06-23
EBI, L.P.
POLARIS SPINAL SYSTEM
2010-05-17
EBI, L.P.
PEANUT GROWTH CONTROL PLATING SYSTEM
2010-04-16
EBI, L.P.
ESL SPINAL SYSTEM
2010-02-04
EBI, L.P.
BIOMET VISION FOOTRING SYSTEM
2009-12-01
EBI, L.P.
BIODRIVE MICRO SCREW SYSTEM
2009-11-19
EBI,LLC D/B/A BIOMET TRAUMA
C-THRU SPINAL SYSTEM
2009-10-15
EBI, L.P.
IBEX SPINAL SYSTEM
2009-08-07
EBI, L.P.
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
2009-07-30
EBI, L.P.
POLARIS SPINAL SYSTEM
2009-07-01
EBI, L.P.
EXPANDABLE PEEK-OPTIMA IMPLANT
2009-01-14
EBI, L.P.
BIOMET ANTERIOR LUMBAR PLATE
2008-11-13
EBI, L.P.
EBI INTERNAL IMPLANT SYSTEM
2008-02-28
EBI, INC.
PRO OSTEON 500R
2007-04-18
EBI, L.P.
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
2006-10-19
EBI, L.P.
SOLITAIRE ANTERIOR SPINAL SYSTEM
2006-10-17
EBI, L.P.
EBI ARAY SPINAL SYSTEM
2006-10-06
EBI, L.P.
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
2006-08-11
EBI, L.P.
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
2006-07-25
EBI, L.P.
EBI ARRAY SPINAL SYSTEM
2006-06-23
EBI, L.P.
EBI ESL PEEK-OPTIMA SPINE SYSTEM
2006-06-08
EBI, L.P.
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
2006-05-24
EBI, L.P.
EBI VERTEBROPLASTY SYSTEMS
2006-03-13
EBI, L.P.
EBI ANTERIOR CERVICAL PLATE SYSTEM
2006-03-06
EBI, L.P.
EBI DYNAFIX VISION FOOTPLATE SYSTEM
2005-09-21
EBI, L.P.
EBI TROCHANTERIC NAIL SYSTEM
2005-02-16
EBI, L.P.
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
2004-12-13
EBI, L.P.
EBI CAS SPINE SPACER SYSTEM
2004-10-27
EBI, L.P.
EBI PERIARTICULAR PLATING SYSTEM
2004-09-16
EBI, L.P.
EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
2004-08-16
EBI, L.P.
EBI XFIX DFS SYSTEM
2004-07-06
EBI, L.P.
EBI DISTAL RADIUS PLATING SYSTEM
2004-06-25
EBI, L.P.

104 records. Showing 1-40. Next

GUDID#

Biomet SpinalPak / OrthoPak - ELECTRODES, 63B, SPINALPAK/ORTHOPAK
EBI, LLC
2016-06-07
Biomet SpinalPak / OrthoPak - ELECTRODES, LT-4500
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - ELECTRODES 72R, SOFT TOUCHREPLACEMENT
EBI, LLC
2014-09-19
Biomet EBI Bone Healing System - SFLX 2 COIL
EBI, LLC
2014-09-19
Reficio DBM Paste - 20700221
EBI, LLC
2015-10-19
Reficio DBM Paste - 20700321
EBI, LLC
2015-10-19
Reficio DBM Paste - 20700421
EBI, LLC
2015-10-19
Reficio DBM Plus - 20800521
EBI, LLC
2015-10-19
Reficio DBM Plus - 20900321
EBI, LLC
2015-10-19
Reficio DBM Plus - 20900421
EBI, LLC
2015-10-19
Reficio DBM Plus - 20900521
EBI, LLC
2015-10-19
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - 1067716-45
EBI, LLC
2019-02-28
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - 1067716-63
EBI, LLC
2019-02-28
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - 1067716-72
EBI, LLC
2019-02-28
Biomet OrthoPak Non-invasive Bone Growth Stimulator System - 1067718-45
EBI, LLC
2019-02-28
Biomet OrthoPak Non-invasive Bone Growth Stimulator System - 1067718-63
EBI, LLC
2019-02-28
Biomet OrthoPak Non-invasive Bone Growth Stimulator System - 1067718-72
EBI, LLC
2019-02-28
Biomet SpinalPak / OrthoPak - BELT EXTENSION, LARGE, SPINALPAK
EBI, LLC
2016-06-07
EBI OsteoGen Implantable Bone Growth Stimulator - OSteoGen 20/F
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-20/S
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-20/M
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-40/ML
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-40/SL
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-20/ML
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-20/SL
EBI, LLC
2014-09-19
SpF XL IIb Implantable Spinal Fusion Stimulator - SPF-XL IIB 2/DM
EBI, LLC
2014-09-19
SpF®-XL IIb Implantable Spinal Fusion Stimulator - SPF-XL IIB 2/DW
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-40/M
EBI, LLC
2014-09-19
EBI OsteoGen™ Implantable Bone Growth Stimulator - OSTEOGEN-40/S
EBI, LLC
2014-09-19
SpF®-PLUS-Mini (60 uA/M) - SPF-PLUS 60/M Implantable Spinal Fusion Stimulator
EBI, LLC
2014-09-19
SpF®-PLUS-Mini (60 uA/W) - SPF-PLUS 60/W Implantable Spinal Fusion Stimulator
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - ELECTRODE COVER PATCHES
EBI, LLC
2014-09-19
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - SPINALPAK ASSEMBLY
EBI, LLC
2014-09-19
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System - SPINALPAK STIMULATOR, BIOMET
EBI, LLC
2014-09-19
Biomet OrthoPak Non-invasive Bone Growth Stimulator System - ORTHOPAK ASSEMBLY
EBI, LLC
2014-09-19
Biomet OrthoPak Non-invasive Bone Growth Stimulator System - ORTHOPAK STIMULATOR, BIOMET
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - BATTERY PACK, REPLACEMENT
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - BATTERY PACK CHARGER, REPLACEMENT
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - STIMULATOR HOLSTER, REPLACEMENT
EBI, LLC
2014-09-19
Biomet SpinalPak / OrthoPak - EXTREMITY BAND, REPLACEMENT
EBI, LLC
2014-09-19

77 records. Showing 1-40. Next