510(k) K982139 ยท JEY Plate, Bone
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
| Applicant | Bionx Implants, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 15, 1998 |
| Received | Jun 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982139
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.