510(k) K123908 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
| Applicant | Matrix Surgical USA, Alpharetta GA, US |
| Decision | Substantially Equivalent, Jul 31, 2013 |
| Received | Dec 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2019 | Matrix Surgical Holdings, LLC OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r Terminated |
KKY | None listed |
| Jan 30, 2019 | Matrix Surgical Holdings, LLC OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial r Terminated |
KKY | None listed |
| Feb 28, 2017 | Matrix Surgical Holdings, LLC OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right Terminated |
KKY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.