510(k) K232572
K232572 is an FDA 510(k) premarket notification submitted by Kalitec Direct, LLC Doing Business AS Kalitec Medical for the device "Kalitec Navigated Instrument System". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2023
- Date Received
- August 24, 2023
- 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.