K243461
- 510(k) number
- K243461
- Device name
- Calibrate Interbody Systems
- Applicant
- Alphatec Spine, Inc. CA · US
- Decision date
- 2025-03-04
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243461.pdf
Official FDA record: K243461
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.