K253216
- 510(k) number
- K253216
- Device name
- IntraOp Alignment System; CONTOUR3D Bending System
- Applicant
- Alphatec Spine, Inc. CA · US
- Product code
- SIN — Automated Intraoperative Spinal Rod Bending System
- Decision date
- 2026-06-25
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253216.pdf
Official FDA record: K253216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.