SIN — Automated Intraoperative Spinal Rod Bending System Class II
FDA product code SIN covers "Automated Intraoperative Spinal Rod Bending System", a Class II medical device regulated under 21 CFR 888.3070. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIN
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253216 | alphatec spine | IntraOp Alignment System; CONTOUR3D Bending System | June 25, 2026 |