K232345
- 510(k) number
- K232345
- Device name
- ATEC Posterior Navigated Disc Prep Instruments
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-11-02
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232345.pdf
Official FDA record: K232345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.