The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Xia 3 Spinal System.
| Device ID | K142381 |
| 510k Number | K142381 |
| Device Name: | Xia 3 Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Garry T Hayeck |
| Correspondent | Garry T Hayeck 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-26 |
| Decision Date | 2014-10-21 |
| Summary: | summary |