510(k) K970400 ยท LZK Implant, Malar
BONE SOURCE HYDROXYAPATITE
| Applicant | Orthofix, Inc., Richardson TX, US |
| Decision | Substantially Equivalent, May 2, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970400
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.