510(k) K100061 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Feb 12, 2010 |
| Received | Jan 11, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100061
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.