510(k) K023186 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 17, 2002 |
| Received | Sep 24, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023186
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. . Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. . Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX. Terminated |
JWH | None listed |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.