IntraOp Alignment System; CONTOUR3D Bending System
FDA 510(k) K253216 · Alphatec Spine, Inc.
510(k) numberK253216
Submission
- Device name
- IntraOp Alignment System; CONTOUR3D Bending System
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- September 29, 2025
- Decision date
- June 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SIN – Automated Intraoperative Spinal Rod Bending System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
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.
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Questions and answers
When was IntraOp Alignment System; CONTOUR3D Bending System cleared by the FDA?
IntraOp Alignment System; CONTOUR3D Bending System (K253216) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 269 days after the submission was received.
What is the product code of K253216?
The FDA product code is SIN – Automated Intraoperative Spinal Rod Bending System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.