Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008668801

FEI Number

3008668801

Entity Name

SERF

City/State/Country

DECINES CHARPIEU Rhone, FR

Establishment Address

85 Avenue des Bruyeres, DECINES CHARPIEU Rhone 69150, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111572

PMA Number

N/A

All Registered Proprietary Names

OSTEONICS FLEXIBLE DEPTH GUAGE Meniscal Transplant Set Depth Gauge General Instruments DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme Gauge, Depth Variable Angle Fixation Pangea Platform OMNIFLEX RAVINE Access System Trays CANYON Retractor Systems Trays EVEREST Spinal System Trays Triathlon System Instrument trays Navigated Spine Instruments Trays DENALI Spinal System Trays CHESAPEAKE Stabilization System Trays Cascadia Interbody System Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays NAPA Access System Tornier Q Pedicle Instruments Aequalis Reversed II Eikon LT Sterilization Tray CAYMAN Plate System Trays Tornier Perform Anatomic Glenoid Aequalis Fracture Aequalis Reversed Fracture CASPIAN Spinal System Trays ATP Disc Prep Pangea Platform CAPRI Corpectomy Cage System Trays INBONE Eikon LT SL Sterilization Tray MESA Spinal System Trays Restoration Modular Instrument Trays ALEUTIAN Interbody Systems Trays OZARK Cervical Plate System Trays Tornier Pyrocarbon Aluminum Lid - Universal Triathlon MSI Tray SAHARA Stabilization System Trays Sterilization Box, Lightweight Hoffmann LRF Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays CoCrMo alloy and Biolox® delta ceramic femoral heads; Hype® press-fit hip stems; Novae® XPEO-E liners NOVAE Dual Mobility Acetabular Cup - Crosslinked liner Serf Hip Systems NexFix IMN Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF Xia Blocker Inserter Restoration Modular Trials Tornier Radial Head System XIA Rod Template Stryker Orthopaedics Trials K2M General Instruments Stryker Orthopaedics Templates INFINITY Vikos Allograft System Triathlon MSI Trials NOVAE Dual Mobility Acetabular Cup

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	1996-04-16
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-12-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-05-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-05-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-05-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-05-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-08-04
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2025-08-04
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-08-04
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2025-08-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-08-04
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-08-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-08-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-12-12
HWT	Template	Orthopedic	Class 1	888.4800	2007-03-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-05-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-05-30

Official Correspondent

No official correspondent registered.

US Agent Details

Dervillia Murphy Email: Dervillia.Murphy@stryker.com Phone: (201) 8315113

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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 3008668801. Last updated year: 2026. Please use registration number 3008668801 when referencing this establishment in official correspondence.