FDA.reportPublic FDA data

EBI, LLC

Matched from indexed company URL: EBI Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22428162242816EBI, LLC1N2026-01-011 Gatehall Rd. Suite 303 PARSIPPANY NJ US 07054
30034352523003435252EBI PATIENT CARE, INC.1Y2026-01-01484 Calle E GUAYNABO PR US 00969

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
362691604711620P850035SpF® Implantable Spinal Fusion StimulatorLOE1987-04-30
362721604711620P850035SpF® Implantable Spinal Fusion StimulatorLOE1987-04-30
362691343828957P850022Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator SyLOF1986-02-18
362721343828957P850022Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator SyLOF1986-02-18
362691370116180P790005OsteoGenTM Implantable Bone Growth StimulatorsLOE1980-01-25
362721370116180P790005OsteoGenTM Implantable Bone Growth StimulatorsLOE1980-01-25
362691987108320P790002Biomet(R) EBI BONE Healing SystemLOF1979-11-06
362721987108320P790002Biomet(R) EBI BONE Healing SystemLOF1979-11-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOE41987-04-30
LOF41986-02-18

PMA#

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 -...

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PMN#

104 records. Showing 1-40. Next

GUDID#

92 records. Showing 1-40. Next