The following data is part of a premarket notification filed by Stryker Corp with the FDA for Xia 4.5 Spinal System.
| Device ID | K121342 |
| 510k Number | K121342 |
| Device Name: | XIA 4.5 SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER CORP 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers STRYKER CORP 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2012-05-04 |
| Decision Date | 2012-06-22 |
| Summary: | summary |