510(k) K170496 · NKB Thoracolumbosacral Pedicle Screw System
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
| Applicant | Stryker Corporation, Allendale NJ, US |
| Decision | Substantially Equivalent, May 16, 2017 |
| Received | Feb 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2019 | Howmedica Osteonics Corp. Serrato 9.5mm X 90mm Polyaxial Screw
Catalog Number 482619590
Serrato 9.5mm X 100mm Polyaxial Screw
Catalog Number 4826195100 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.