Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007385214

FEI Number

3007385214

Entity Name

NEURO FRANCE IMPLANTS

City/State/Country

La Ville-aux-Clercs Loir-et-Cher, FR

Establishment Address

25 rue des Ecoles, Z.A. Le Bourg, La Ville-aux-Clercs Loir-et-Cher 41160, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NEURO FRANCE IMPLANTS (Owner Number: 10092038)

Owner / Operator Contact Address

25 rue des Ecoles, Z.A. Le Bourg, La Ville-aux-Clercs, FR-41 41160, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-12-21

Official Correspondent

KARIN WORNER

US Agent Details

Bret McCLUE Email: bmcclue@orthoex.com Phone: (480) 3185805

Related Public Records

Same Entity

NEURO FRANCE IMPLANTS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

Similar Registrations

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3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3005031160	Xtant Medical Holdings, Inc.	Belgrade, MT, US
3023852420	Hipp Medical AG	Renquishausen Baden-Wurttemberg, DE
3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	KADI Gujarat, IN
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007385214. Last updated year: 2026. Please use registration number 3007385214 when referencing this establishment in official correspondence.