Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616062

FEI Number

3003258310

Entity Name

Cousin Biotech

City/State/Country

WERVICQ-SUD Nord, FR

Establishment Address

ALLEE DES ROSES, WERVICQ-SUD Nord 59117, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cousin Surgery (Owner Number: 9043669)

Owner / Operator Contact Address

Allee des roses, Wervicq-Sud, FR-59 59117, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ResCUBE Ligament Fixation System Bandloc Sterile Implant Bandloc Duo Sterile Implant CABSAIR® COMPOSITE CABSAIR® NuVasive® VersaTie System 4DDOME® (Trial Implant)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2022-06-24
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2023-12-21
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2010-12-03
OQL	Mesh, Surgical, Deployment Balloon	General, Plastic Surgery	Class 2	878.3300	2010-12-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2008-12-19
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2023-01-09
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2007-12-03
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2019-06-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-01-09

Official Correspondent

FRANCK PELLETIER

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Cousin Surgery

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
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

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1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
3010162973	Synergy Health Marseille SAS	MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616062. Last updated year: 2026. Please use registration number 9616062 when referencing this establishment in official correspondence.