Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033557813

FEI Number

3033557813

Entity Name

SC MEDICA

City/State/Country

Strasbourg Bas-Rhin, FR

Establishment Address

3 Quai Kleber Tour Sebastopol, Strasbourg Bas-Rhin 67000, FR

Establishment Type(s)

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

Owner / Operator

SC MEDICA (Owner Number: 10091466)

Owner / Operator Contact Address

3 Quai Kleber Tour Sebastopol, Strasbourg, FR-67 67000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232468

PMA Number

N/A

All Registered Proprietary Names

FFX Screw FFX

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	2025-11-24
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-10-09

Official Correspondent

LAILA EL HAIMER

US Agent Details

Bret McClue Business: ORTHOEX Email: bmcclue@orthoex.com Phone: (480) 3185805

Related Public Records

Same Entity

SC MEDICA

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

Registration Number	Establishment Name	Location
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 3033557813. Last updated year: 2026. Please use registration number 3033557813 when referencing this establishment in official correspondence.