510(k) K080778 ยท HWC Screw, Fixation, Bone
ENSPLINT TM BONE SCREW
| Applicant | Sonoma Orthopedic Products, Inc., Santa Rosa CA, US |
| Decision | Substantially Equivalent, Jul 10, 2008 |
| Received | Mar 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080778
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.