510(k) K922489 ยท FWP Prosthesis, Chin, Internal
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
| Applicant | Porex Technologies Corp., Fairburn GA, US |
| Decision | Substantially Equivalent, Sep 2, 1992 |
| Received | May 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026
Product Usage:
MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weig Terminated |
FWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.