510(k) K171037 ยท JOF Polymer, Ent Synthetic, Porous Polyethylene
PoreStar Patient Specific Implant
| Applicant | Anatomics Pty, Ltd., St Kilda, AU |
| Decision | Substantially Equivalent, Dec 27, 2017 |
| Received | Apr 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171037
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.