510(k) K011912 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
| Applicant | Axya Medical, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 31, 2001 |
| Received | Jun 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011912
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.