510(k) K972629 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
DEPUY AE TK2 HIP SCREW SYSTEM
| Applicant | Depuy, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 9, 1997 |
| Received | Jul 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972629
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2008 | Depuy Orthopaedics, Inc. Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Orthopaedics, Inc., Warsaw, IN 46581 Terminated |
KTT | None listed |
| Jan 24, 2008 | Depuy Orthopaedics, Inc. Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.