Data / Medical devices / France / Amplitude
Amplitude: FDA-registered device maker in Valence Drome, France, 2 510(k) clearances
Amplitude is registered with the FDA (registration 3009590742) in Valence Drome, France. It lists 24 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009590742
- Address
- 11 Cours Jacques Offenbach Zone Mozart 2, Valence Drome, France, 26000
- Owner or operator
- AMPLITUDE (10054515)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- March 28, 2017
- Registered through
- 2026
- Brand names listed
- Anatomic Total Knee System, Chisel, Clamp, Connector for E.T.O.I.L.E, Cutting instrument, Drill bit, Driver, Extractor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2023 | K230078 | TRAX® CR Total Knee System | JWH | Substantially Equivalent | Amplitude | accessdata.fda.gov |
| January 19, 2017 | K161414 | Anatomic Total Knee System | JWH | Substantially Equivalent | Amplitude | accessdata.fda.gov |
Compare with other makers
- All makers of Osteotome
- All makers of Table, Surgical With Orthopedic Accessories, Manual
- All makers of Retractor
- All makers of Hammer, Surgical
- All makers of Extractor
- All makers of Forceps
Updated November 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.