Clearance Summary
IntraOp Alignment System; CONTOUR3D Bending System received FDA 510(k) clearance under submission number K253216, sponsored by Alphatec Spine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-06-25.
- Submission: K253216
- Applicant / Sponsor: Alphatec Spine, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2026-06-25
Classification & Regulation
This clearance is catalogued under FDA product code SIN and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.