510(k) K060361 ยท NKB Thoracolumbosacral Pedicle Screw System
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Mar 6, 2006 |
| Received | Feb 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2009 | Stryker Spine Stryker Xia Dual Anterior Staple;
Non Sterile; Catalog number 03820115;
Manufactured by Stryker Spine SAS, Cestas, France;
Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430
Single use device Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.