Data / Medical devices / Hungary / SANATMETAL Ltd.
SANATMETAL Ltd.: FDA-registered device maker in Eger, Hungary, 1 510(k) clearance
SANATMETAL Ltd. is registered with the FDA (registration 3002962587) in Eger, Hungary. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 7, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002962587
- Address
- Faiskola ut 5, Eger, Hungary, H-3300
- Owner or operator
- SanatMetal Ltd. (10024782)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 21, 2008
- Registered through
- 2026
- Brand names listed
- Sanatmetal IM Nails and Pins, Sanatmetal SpectruM Trochanter Nail
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 7, 2008 | K070761 | SANATMETAL NAILS AND PINS | HSB | Substantially Equivalent | Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. | accessdata.fda.gov |
Compare with other makers
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
Updated February 7, 2008. 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.