SIN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Automated Intraoperative Spinal Rod Bending System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Medical specialty
- Orthopedic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IntraOp Alignment System; CONTOUR3D Bending System (K253216) | Alphatec Spine, Inc. | 2026-06-25 |
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Every clearance here is in the API, with alerts when new ones post.