IntraOp Alignment System; CONTOUR3D Bending System— 510(k) K253216
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K253216 for IntraOp Alignment System; CONTOUR3D Bending System, Substantially Equivalent on 2026-06-25. Applicant: Alphatec Spine, Inc.. Device class: 2.
Summary
Alphatec Spine's clearance names two systems, the IntraOp Alignment System and the CONTOUR3D Bending System. The record lists one product code, SIN, automated intraoperative spinal rod bending systems.
Class II, 21 CFR 888.3070. The Radiology review panel handled it as a Traditional 510(k), though the record lists Orthopedic as the classification panel.
Alphatec filed from Carlsbad, California. Review took 269 calendar days (September 29, 2025 to June 25, 2026).
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Product code SIN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.