510(k) K040364 ยท FTM Mesh, Surgical
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
| Applicant | Porex Surgical, Inc., Newnan GA, US |
| Decision | Substantially Equivalent, Jun 30, 2004 |
| Received | Feb 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2021 | Stryker Leibinger GmbH & Co. KG MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 Terminated |
FTM | None listed |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right
Product Usage:
MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications Terminated |
FTL | None listed |
| Jan 27, 2012 | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial rec Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.