510(k) K100805 ยท NQW Orthosis, Spine, Plate, Laminoplasty, Metal
GALLERY LAMINOPLASTY FIXATION SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 20, 2010 |
| Received | Mar 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100805
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.