The following data is part of a premarket notification filed by Stryker Spine with the FDA for Xia 3 Spinal System.
| Device ID | K113666 |
| 510k Number | K113666 |
| Device Name: | XIA 3 SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | G. Stiegman |
| Correspondent | G. Stiegman STRYKER SPINE 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-08-28 |
| Summary: | summary |