510(k) K253216
K253216 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "IntraOp Alignment System; CONTOUR3D Bending System". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code SIN (Automated Intraoperative Spinal Rod Bending System), a Class II device regulated under 21 CFR 888.3070. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2026
- Date Received
- September 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Intraoperative Spinal Rod Bending System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod.