Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033809758

FEI Number

3033809758

Entity Name

NORAKER

City/State/Country

LYON Auvergne-Rhone-Alpes, FR

Establishment Address

60 avenue Rockefeller, LYON Auvergne-Rhone-Alpes 69008, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NORAKER (Owner Number: 10090225)

Owner / Operator Contact Address

60 avenue Rockefeller, LYON, FR-ARA 69008, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AktiBone Granules MectaBlast Granules GlassBone Granules GRAFTYS QUICKSET KIT GRAFTYS QUICKSET ARTHREX QUICKSET KIT ARTHREX QUICKSET GRAFTYS QUICKSET DELIVERING GUN ARTHREX QUICKSET DELIVERING GUN ARTHREX QUICKSET KIT GRAFTYS QUICKSET KIT ARTHREX QUICKSET GRAFTYS QUICKSET GRAFTYS CANNULA 7G ARTHREX QUICKSET CANNULA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-12-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-12-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-12-22
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2025-12-22

Official Correspondent

CATHERINE FLACARD

US Agent Details

ELISA MALDONADO-HOLMERTZ Business: Obelix Consulting Email: elisamh@obelixconsult.com Phone: (512) 4316069

Related Public Records

Same Entity

NORAKER

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
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3007738819	OSferionBiomaterials Corp. Mishima Factory	Sunto-gun Shizuoka, JP
3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033809758. Last updated year: 2026. Please use registration number 3033809758 when referencing this establishment in official correspondence.