Data / Medical devices / France / Cousin Biotech

Cousin Biotech: FDA-registered device maker in WERVICQ-SUD Nord, France, 4 510(k) clearances

Name: Cousin Biotech FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cousin Biotech is registered with the FDA (registration 9616062) in WERVICQ-SUD Nord, France. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 29, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616062
FEI number: 3003258310
Address: Allee Des Roses, WERVICQ-SUD Nord, France, 59117
Owner or operator: Cousin Surgery (9043669)
Roles: Contract manufacturer, Manufacturer
First device listed: December 3, 2007
Registered through: 2026
Brand names listed: 4DDOME®, 4DDOME® (Trial Implant), Bandloc Duo Sterile Implant, Bandloc Sterile Implant, CABSAIR®, CABSAIR® COMPOSITE, NuVasive® VersaTie System, ResCUBE Ligament Fixation System

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Contract manufacturer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical, Deployment Balloon	OQL	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Contract manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Contract manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Contract manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 29, 2018	K181799	ResCUBE Ligament Fixation System	OWI	Substantially Equivalent	Cousin Biotech Sas	accessdata.fda.gov
June 25, 2010	K093196	BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09	FTL	Substantially Equivalent	Cousin Biotech Sas	accessdata.fda.gov
June 26, 2008	K072962	CABS'AIR	FTL	Substantially Equivalent	Cousin Biotech Sas	accessdata.fda.gov
August 22, 2007	K070918	4DDOME	FTL	Substantially Equivalent	Cousin Biotech	accessdata.fda.gov

Compare with other makers

Updated August 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.