The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory.
| Device ID | K170496 |
| 510k Number | K170496 |
| Device Name: | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
| Contact | Meriam Gabera |
| Correspondent | Meriam Gabera, Ms, Rac Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-05-16 |
| Summary: | summary |