510(k) K043250 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
| Applicant | Stryker Leibinger, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Apr 15, 2005 |
| Received | Nov 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043250
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101.
Custom cranial implant designed individually for each patient to correct t Terminated |
KKY | None listed |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102.
Custom cranial implant designed individually for each patient to correct Terminated |
KKY | None listed |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00103.
Custom cranial implant designed individually for each patient to correct t Terminated |
KKY | None listed |
| Dec 18, 2008 | Stryker Craniomaxillofacial Division Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104.
Custom cranial implant designed individually for each patient to cor Terminated |
KKY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.