510(k) K021357 ยท HPZ Implant, Eye Sphere
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
| Applicant | Porex Surgical, Inc., Newnan GA, US |
| Decision | Substantially Equivalent, Aug 5, 2002 |
| Received | Apr 29, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2012 | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye gl Terminated |
HPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.