FDA product code SIN: Automated Intraoperative Spinal Rod Bending System
SIN is the FDA product code for automated intraoperative spinal rod bending system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under SIN, 1 in the last five years. The average 510(k) review took 269 days (median 269); 269 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Automated Intraoperative Spinal Rod Bending System |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for SIN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 269 |
Compare with all 510(k) review times · Search every SIN clearance
Top SIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alphatec Spine, Inc. | 1 | 2026-06-25 |
Most recent SIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253216 | Alphatec Spine, Inc. | IntraOp Alignment System; CONTOUR3D Bending System | 2026-06-25 | 269 |
Recalls for SIN devices
openFDA lists no recalls for product code SIN.
Frequently asked questions
What is FDA product code SIN?
SIN is the FDA product code for automated intraoperative spinal rod bending system. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is SIN?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code SIN?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most SIN clearances?
Alphatec Spine, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SIN
- Run a recall and safety report across every SIN manufacturer
- Watch product code SIN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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