510(k) K091359 ยท KWP Appliance, Fixation, Spinal Interlaminal
GSO PCT SPINAL SYSTEM
| Applicant | Gold Standard Orthopaedics, LLC, Louisville KY, US |
| Decision | Substantially Equivalent, Sep 2, 2009 |
| Received | May 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091359
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.