Home › Device types › OSF
Patient Specific Manual Orthopedic Stereotaxic System
FDA product code OSF · Class 2 · Neurology
0
Registered devices
0
Adverse events
1
Recalls
3
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-23 | Materialise N.V. | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
