510(k) K010554 ยท HWC Screw, Fixation, Bone
MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A
| Applicant | Bionx Implants, Inc., Tampere, FI |
| Decision | Substantially Equivalent, May 25, 2001 |
| Received | Feb 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010554
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.