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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

DateFirmReason
2015-09-23Materialise N.V.Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.