FH Industrie
FranceFDA 510(k) applicant, unverified FDA FEI 3003898228
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What FH Industrie makes
FH Industrie manufactures orthopaedic shoulder prostheses and related surgical hardware, including humeral inserts, reverse shoulder systems, and intramedullary nailing devices for humeral fractures. Their portfolio includes modular humeral stems, glenoid components for reverse shoulder arthroplasty, and software tools for preoperative planning and simulation. The company also produces short-stem humeral systems designed for primary or revision shoulder arthroplasty.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their compliance with US regulatory requirements. FH Industrie operates as a manufacturer based in the United States.
Catalogue
ARROW Off-Centred Humeral Insert Ref K232226
510(k) 510(k)e-Ortho Shoulder Software Ref K201928
510(k) 510(k)JARVIS Glenoid Reverse Shoulder Prosthesis Ref K242253
510(k) 510(k)e-Ortho Shoulder Software v1.1 Ref K220758
510(k) 510(k)ARROW Short Stem Humeral System Ref K202024
510(k) 510(k)JARVIS Metaphyseal Stem Ref K254003
510(k) 510(k)JARVIS Glenoid Reverse Shoulder Prosthesis Ref K252411
510(k) 510(k)JARVIS Diaphyseal Stem Standard Ref K253345
510(k) 510(k)TELEGRAPH® EVOLUTION Humeral Nailing System Ref K200127
510(k) 510(k)
Company details
- FDA FEI number
- 3003898228
- Address
- ZI DE KERNEVEZ-6 RUE NOBEL, QUIMPER Finistere
Frequently asked questions
How many devices does FH Industrie have in the registry?
The registry currently lists 9 devices for FH Industrie. Devices recorded under merged duplicate company entries are counted once.
Which registries list FH Industrie's devices?
Among its 9 most recently registered devices, FH Industrie has devices listed in FDA 510(k) (9 devices).
What risk classes do FH Industrie's devices fall under?
Among its 9 most recently registered devices, the classes recorded for FH Industrie's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from FH Industrie in the registry?
The most recently registered devices listed for FH Industrie include ARROW Off-Centred Humeral Insert, e-Ortho Shoulder Software, JARVIS Glenoid Reverse Shoulder Prosthesis and e-Ortho Shoulder Software v1.1.