510(k) K924935 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
| Applicant | Polyclinic Medical Center, Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 2, 1993 |
| Received | Sep 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2016 | Biomet Microfixation, LLC Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.
HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/d Terminated |
KKY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.