510(k) K071373 ยท NKB Thoracolumbosacral Pedicle Screw System
STRYKER SPINE XIA III SPINAL SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Aug 27, 2007 |
| Received | May 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2012 | Stryker Spine Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026.
Product Usage: :
Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.