Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006563559

FEI Number

3006563559

Entity Name

CEFIMECA

City/State/Country

La Talaudiere Loire, FR

Establishment Address

15 rue de la Chazotte, La Talaudiere Loire 42350, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cefimeca (Owner Number: 10035460)

Owner / Operator Contact Address

15 rue de la Chazotte, La Talaudiere, FR-42 42350, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Idys ALIF 3DTi Erisma LP JARVIS Glenoid Reverse Shoulder Prosthesis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-12-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-02-28
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-02-24
HTO	Reamer	Orthopedic	Class 1	888.4540	2016-02-24
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2018-04-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-06-21
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2025-05-12
HWB	Extractor	Orthopedic	Class 1	888.4540	2016-02-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-05-12
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2025-05-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-06-21
HJT	Haploscope	Ophthalmic	Class 1	886.1340	2021-02-25
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-02-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-06-21
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-06-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-06-21
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2023-06-21
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-12-28
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2018-04-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-30
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2018-02-05
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2018-02-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-02-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-06-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-06-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-06-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-05-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-30
HWT	Template	Orthopedic	Class 1	888.4800	2018-02-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-06-21
HWJ	Awl	Orthopedic	Class 1	888.4540	2016-02-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-06-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-06-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-06-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-21
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2016-02-24
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-02-20
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-12-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-06-21
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-06-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-06-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-06-21
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2023-06-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-01-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-01-09
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2023-06-21
HWK	Trephine	Orthopedic	Class 1	888.4540	2013-12-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-05-12
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-05-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-05-12
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-06-21
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2017-03-14
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-04-16
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-12-30

Official Correspondent

Frederic Mazenod

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Cefimeca

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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22

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.

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006563559. Last updated year: 2026. Please use registration number 3006563559 when referencing this establishment in official correspondence.