510(k) K083393 ยท NKB Thoracolumbosacral Pedicle Screw System
XIA 3 SPINAL SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 1, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2010 | Stryker Spine Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565.
Not Sterile;
Manufactured by Stryker Spine, SA, Cestas, France.
Distributed in the USA by Stryker Spine, Allendale, NJ
Inte Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.