510(k) K183196
K183196 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker". The FDA issued a decision of Substantially Equivalent on February 14, 2019. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stryker Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2019
- Date Received
- November 19, 2018
- 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
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.