Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008696586

FEI Number

3008696586

Entity Name

CLAYENS GENAS

City/State/Country

Genas Rhone, FR

Establishment Address

10 Rue Jean Rostand, Genas Rhone 69740, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CLAYENS GENAS (Owner Number: 10043061)

Owner / Operator Contact Address

10 rue jean rostand, Genas, FR-69 69740, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NCB®-PH, graphic case, module instr. NCB®-PH, graphic case, cover NCB®-PH, graphic case, module MIS instruments NCB®-PH, graphic case, module MIS screw rack NCB®-PH, graphic case, base (Inox) NCB®-PH, graphic case, module implants NCB®-PH, graphic case, module screw rack NCB®-PH, graphic case, module instruments NCB®-PH, graphic case, module instruments, empty AS FX REVISION TRAY (EMPTY) RESURFACING Insert f.tray Femur 2(empty) MEMOCLIP - INSTRUMENTS INSERT WITH 53 SILICONE EYELETS+STRIPE ALPHA Insert plastic tray CORAIL SZ 6 Tray FIXOS - INSTRUMENTS Insert (empty) ANATOMICAL Tray for rasps (empty) Small tray cover grey ANCHORAGE PLATING - INSTRUMENTS RESURF. Base tray I Acetabular curved RESURF. Base tray Femur II (empty) Insert f. tray Cone Prosthesis, empty ANATOMICAL Revision Tray (empty) ANATOMICAL Insert for tray rasps EMPTY BOX THERMO SCARF AUTOCLAVE CONTAINER TWIST OFF SCREW TRAY autoclave container X-FUSE - INSTRUMENTS AS B/F Tray Insert I (empty) INSERT WITH 48 SILICONE EYELETS+STRIPE TRAY, SURGICAL, INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Device Family name AUTOCLAVE CONTAINER BOITE THERMOFORMEE AGRAFE A MEMOIRE DE FORME container lid standard AUTOFIX TRAY WITH LID 2/2.5 mm 6.5 SET BASE AUTOFIX IMPLANT AND INSTRUMENT CASE I.CO.S Small container cover, blue RESURFACING Base tray Acetabulum (empty) Tray 2, Wagner Revision, empty STANDARD STAPLE TRAY Wagner SL Insert tray awls, empty OTHER - INSTRUMENTS AS FX Tray (empty) AS Inverse tray (empty) ANATOMICAL Tray for Impactor (empty) Wagner Cone Trial stems tray insert CORAIL SZ COVER EASY CLIP SI - INSTRUMENTS Tray Cone Prosthesis, empty AS Tray for keeled glenoid (empty) Standard tray cover grey INSERT WITH 69 SILICONE EYELETS+ STRIPE Wagner Cone Trial stems tray, empty ALPHA plastic tray THERMO STAPPLES BOX Wagner SL Revision tray trial stems AS FX Insert II for tray (empty) SMART TOE - INSTRUMENTS Wagner SL Rev. Tray Base Instr., empty AS Inverse Insert for tray (empty) Standard container cover, blue NCB®-DF graphic case, module instruments AS FX Insert for tray (empty) Tray for glenoid (empty) RESURF. Base tray Femur plan (empty) EMPTY BOX RESURFACING Insert for tray Cups (empty) RESURF. Base tray Acet. curved (empty) Wagner SL Insert tray base instr, empty AS B/F Single Tray (empty) BOX DESIGN 1814. COLOR LIGHT BEIGE. AS RESURF. Tray shell Acet. Curved

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-12-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

CLAYENS GENAS

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008696586. Last updated year: 2026. Please use registration number 3008696586 when referencing this establishment in official correspondence.