The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Xia 4.5 Spinal System.
| Device ID | K142114 |
| 510k Number | K142114 |
| Device Name: | XIA 4.5 SPINAL SYSTEM |
| Classification | Growing Rod System |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Garry T Hayeck, Ph.d. |
| Correspondent | Garry T Hayeck, Ph.d. STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | PGM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-10-27 |
| Summary: | summary |