The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Xia 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory.
| Device ID | K152632 |
| 510k Number | K152632 |
| Device Name: | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Soraya King |
| Correspondent | Soraya King STRYKER CORPORATION 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 | 2015-09-15 |
| Decision Date | 2015-12-02 |
| Summary: | summary |