FH Industrie
QUIMPER Finistere, FR
FH INDUSTRIE appears in FDA device records in QUIMPER Finistere, FR. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for FH Industrie between 2020 and 2026. The busiest year on record is 2020, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254003 | JARVIS Metaphyseal Stem | PHX | Substantially Equivalent | |
| K253345 | JARVIS Diaphyseal Stem Standard | PHX | Substantially Equivalent | |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | PHX | Substantially Equivalent | |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | PHX | Substantially Equivalent | |
| K232226 | ARROW Off-Centred Humeral Insert | PHX | Substantially Equivalent | |
| K220758 | e-Ortho Shoulder Software v1.1 | LLZ | Substantially Equivalent | |
| K202024 | ARROW Short Stem Humeral System | PHX | Substantially Equivalent | |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | HSB | Substantially Equivalent | |
| K201928 | e-Ortho Shoulder Software | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003898228 | 3003898228 | FH INDUSTRIE | ZI DE KERNEVEZ-6 RUE NOBEL, QUIMPER Finistere 29000 FR | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- PHXShoulder Prosthesis, Reverse Configuration
- LLZSystem, Image Processing, Radiological
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets FH Industrie edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain