IntraOp Alignment System; CONTOUR3D Bending System
FDA 510(k) clearance K253216 · decided 2026-06-25
Clearance details
- K-number
- K253216
- Device name
- IntraOp Alignment System; CONTOUR3D Bending System
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-25
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- SIN
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.