FH INDUSTRIE

FDA Device Registration & Listing · QUIMPER Finistere, FR · Registration 3003898228

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003898228
FEI Number
3003898228
Entity Name
FH INDUSTRIE
City/State/Country
QUIMPER Finistere, FR
Establishment Address
ZI DE KERNEVEZ-6 RUE NOBEL, QUIMPER Finistere 29000, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FH ORTHOPEDICS INC (Owner Number: 9025586)
Owner / Operator Contact Address
ORTHO EXPRESS LLC, 7327 E. TIERRA BUENA LANE, Scottsdale, AZ 85260, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K150568
PMA Number
N/A

All Registered Proprietary Names

Instrument set ARROW reverse shoulder system BePOD EZ WEIL Screws ARROW Anatomical Porous Glenoid JARVIS Diaphyseal Stem Standard ARROW Short Stem Humeral System ARROW Off-Centred Humeral Insert ARROW® Reverse Shoulder long keel and short keel glenoid base JARVIS Metaphyseal Stem CoLS PEEK CoLS Fixation System BePOD Cannulated Arthrodesis screws JARVIS Glenoid Reverse Shoulder Prosthesis e-Ortho Shoulder Software v1.1 TELEGRAPH EVOLUTION Humeral Nailing System e-Ortho Shoulder Software ARROW® Reverse Porous Glenoid ARROW Humeral stems size 6 and 16

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2011-01-11
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2012-09-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2012-09-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2012-09-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-09-14
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2017-04-20
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2017-04-20
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2017-04-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-12-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-12-11
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-12-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-01-17
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-01-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-01-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-08-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-03-20
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-01-13
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-01-13
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-01-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-02-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-06
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2024-11-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-11-27
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-11-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-11-22
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2020-11-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-02
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-01-25
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-01-25
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-01-25
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2015-12-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-12-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2015-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240117

Related Public Records

Same Entity

FH ORTHOPEDICS INC
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
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003898228. Last updated year: 2026. Please use registration number 3003898228 when referencing this establishment in official correspondence.
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