Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242816

FEI Number

2242816

Entity Name

EBI, LLC

City/State/Country

PARSIPPANY, NJ, US

Establishment Address

1 Gatehall Rd., Suite 303, PARSIPPANY, NJ 07054, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

EBI, LLC - AHP EOS Buyer Inc. (Owner Number: 2242816)

Owner / Operator Contact Address

1 Gatehall Drive, Suite 303, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P850035

All Registered Proprietary Names

EBI Osteogen Implantable Growth Sti SpinalPak II Bone Growth Stimulator OrthoPak 2 Bone Growth Stimulator S Biomet OrthoPak Non-invasive Bone Growth Stimulator System Biomet Spinalpak Non-invasive Spine Fusion Stimulator System SPF- 60 Spinal Fusion Stimulator SpF Plus-Mini (60uA/W) & SpF Plus-Mini (60uA/M) EBI SPF Implantable Spinal Fusion S SPF-Plus 60/W & SPF-Plus 60/M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOE	Stimulator, Invasive Bone Growth	Unknown	Class 3	N/A	2008-02-27
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	Class 2	890.5870	2008-02-27
LOE	Stimulator, Invasive Bone Growth	Unknown	Class 3	N/A	2008-02-27

Official Correspondent

Robert Kokowitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EBI, LLC - AHP EOS Buyer Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003435252	EBI PATIENT CARE, INC.	GUAYNABO, PR, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-06	N/A	2	EBI Trochanteric 11mm Long Nail.

Similar Registrations

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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3003435252	EBI PATIENT CARE, INC.	GUAYNABO, PR, US
3017264244	DJO, LLC	Carlsbad, CA, US
3007611554	CREATION TECHNOLOGIES LTD	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242816. Last updated year: 2026. Please use registration number 2242816 when referencing this establishment in official correspondence.