510(k) K011569 ยท JEY Plate, Bone
BIOSORBFX O/M 2.0/2/4 SYSTEM
| Applicant | Bionx Implants, Inc., Tampere, FI |
| Decision | Substantially Equivalent, Feb 22, 2002 |
| Received | May 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011569
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.