510(k) K051309 ยท HWC Screw, Fixation, Bone
ROI FUSION RODS & PLATES
| Applicant | Reiley Orthopaedics, Inc., Round Rock TX, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | May 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2011 | Wright Medical Technology Inc ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355,
IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN Terminated |
HWC | None listed |
| Jun 17, 2011 | Wright Medical Technology Inc ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002
The ENDO Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.