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Orthopedic Stereotaxic Instrument

FDA product code OLO · 420 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-01-15 – 2026-08-20

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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