510(k) K251316
K251316 is an FDA 510(k) premarket notification submitted by Mazor Robotics , Ltd. for the device "Mazor X System / Mazor X Stealth Edition". The FDA issued a decision of Substantially Equivalent on Sep 11, 2025. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Mazor Robotics , Ltd. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2025
- Date Received
- Apr 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthopedic Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
- 510(k)
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.