Data / Medical devices / Spain / Ames Medical Prosthetic Solutions, S.A.U.
Ames Medical Prosthetic Solutions, S.A.U.: FDA-registered device maker in St. Feliu del Llobregat Barcelona, Spain, 1 510(k) clearance
Ames Medical Prosthetic Solutions, S.A.U. is registered with the FDA (registration 3036718423) in St. Feliu del Llobregat Barcelona, Spain. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036718423
- Address
- Ctra. Laurea Miro, 388, St. Feliu del Llobregat Barcelona, Spain, 08980
- Owner or operator
- AMES MEDICAL Prosthetic Solutions, S.A.U. (10092888)
- Roles
- Manufacturer
- First device listed
- March 3, 2025
- Registered through
- 2026
- Brand names listed
- OsteoSinter® EVANS and COTTON wedges and related accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Wedge | PLF | 2 | 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 |
|---|---|---|---|---|---|---|
| December 6, 2024 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | PLF | Substantially Equivalent | Ames Medical Prosthetic Solutions, S.A.U. | accessdata.fda.gov |
Compare with other makers
Updated December 6, 2024. 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.