K232572
- 510(k) number
- K232572
- Device name
- Kalitec Navigated Instrument System
- Applicant
- Kalitec Direct, LLC Doing Business AS Kalitec Medical FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-12-13
- Date received
- 2023-08-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232572.pdf
Official FDA record: K232572
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.