EBI Inc

FDA Filings

This page includes the latest FDA filings for EBI Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
EBI Inc.
Internal Hex Implant System2020-01-22
EBI Inc.
Internal Octa Implant System2017-08-31
EBIT Srl
SUITESTENSA2017-06-23
EBI Inc
EBI External Implant System2015-03-27
EBI, LLC
NEXTGEN ALTIUS OCT SYSTEM2014-12-15
EBI, LLC
POLARIS SPINAL SYSTEM -TRANSLATION SCREW2014-04-24
EBI, LLC
SOLITAIRE-C CERVICAL SPACER SYSTEM2012-04-26
EBI, LLC
CONSTRUX EXTERNAL FIXATION DEVICE2011-08-03
EBI, L.P.
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM2010-06-23
EBI, L.P.
POLARIS SPINAL SYSTEM2010-05-17
EBI, L.P.
PEANUT GROWTH CONTROL PLATING SYSTEM2010-04-16
EBI, L.P.
ESL SPINAL SYSTEM2010-02-04
EBI, L.P.
BIOMET VISION FOOTRING SYSTEM2009-12-01
EBI,LLC D/B/A BIOMET TRAUMA
BIODRIVE MICRO SCREW SYSTEM2009-11-19
EBI, L.P.
POLARIS SPINAL SYSTEM2009-07-01
EBI, L.P.
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM2006-10-19
EBI, L.P.
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM2006-05-24
EBI, L.P.
EBI DYNAFIX VISION FOOTPLATE SYSTEM2005-09-21
EBI, L.P.
EBI TROCHANTERIC NAIL SYSTEM2005-02-16
EBI, L.P.
EBI XFIX DFS SYSTEM2004-07-06
EBI, L.P.
EBI DYNAFIX COMPRESSION BONE SCREW2003-03-20
EBI, L.P.
EBI XFIX DFS SYSTEM2002-10-25
EBI, L.P.
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM2002-06-20
EBI, L.P.
EBI XFIX RAIL SYSTEM2002-05-16
EBI, L.P.
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR2002-03-08
EBI, L.P.
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2002-02-05
EBI, L.P.
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2002-01-17
EBI, L.P.
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM2001-06-29
EBI, L.P.
EBI DYNAFIX VS OSTEOTOMY SYSTEM2001-05-17
EBI, L.P.
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM2000-10-23

Latest Premarket Applications

PMAManufacturerDevice NameDate
EBI, LLC
Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys2019-12-03
EBI, LLC
OsteoGen Surigically Implantable Bone Growth Stimulators2019-07-18
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2019-07-18
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-11-02
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-11-02
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-05-07
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-05-07
EBI, LLC
EBI OsteoGen Impantable Bone Growth Stimulators2018-05-04
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-05-04
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-04-26
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-04-26
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-03-30
EBI, LLC
Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System2018-03-30
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-03-30
EBI, LLC
Biomet EBI Bone Healing System2018-03-30
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-03-29
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-03-29
EBI, LLC
SPF Implantable Spinal Fusion Stimulators2018-03-14
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2018-03-14
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-03-14
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2018-03-14
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2017-06-02
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2017-06-02
EBI, LLC
SpF Implantable Spinal Fusion Stimulators2017-03-27
EBI, LLC
EBI OsteoGen Implantable Bone Growth Stimulators2017-03-27
EBI, LLC
BIOMET EBI BONE HEALING SYSTEM2016-12-08
EBI, LLC
BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM2016-12-08
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 (62016-11-17
EBI, LLC
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR2016-03-18
EBI, LLC
BIO OSTEOGEN SYSTEM 2042016-03-07

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
BestDuo Abutment Screw
EBI Inc.2019-11-08
Implant Analog
EBI Inc.2019-11-08
BLT Octa Analog
EBI Inc.2019-11-08
Implant Analog Wide
EBI Inc.2019-11-08
Implant Analog
EBI Inc.2019-11-08
BLT OS Impression Coping
EBI Inc.2019-11-08
BestDuo Abutment
EBI Inc.2019-11-08
BestDuo Abutment
EBI Inc.2019-11-08
BestDuo Abutment
EBI Inc.2019-11-08
BestDuo Abutment
EBI Inc.2019-11-08
BestDuo Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
BESTic Healing Abutment
EBI Inc.2019-11-08
Precision Gold UCLA Abutment
EBI Inc.2019-11-08
CCM UCLA Abutment (for BESTic) [Non-Octa]
EBI Inc.2019-11-08
CCM UCLA Abutment (for BESTic) [OCT]
EBI Inc.2019-11-08
CCM UCLA Abutment (for Precision) [Non-Octa]
EBI Inc.2019-11-08
CCM UCLA Abutment (for Precision) [OCT]
EBI Inc.2019-11-08
EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
EBI OsteoGen Implantable Bone Growth Stimulator
EBI, LLC2018-07-06
Biomet SpinalPak / OrthoPak
EBI, LLC2018-07-06
Biomet SpinalPak / OrthoPak
EBI, LLC2018-07-06
Biomet EBI Bone Healing System
EBI, LLC2018-07-06
Biomet Bone Healing System
EBI, LLC2018-07-06
Biomet EBI Bone Healing System
EBI, LLC2018-07-06
Biomet EBI Bone Healing System
EBI, LLC2018-07-06

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Legal Entity Identifier 969500V9BSEN0HWUIC23 [EBI SA] Legal Entity Identifier 391200YM3O89Z5S6HS55 [Ebi.in GmbH] D.U.N.S. 082072240 [EBIX INC]

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