510(k) K060969 ยท HRS Plate, Fixation, Bone
POLYAX LOCKED PLATING SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 12, 2006 |
| Received | Apr 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060969
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 6 hole, Sterile, REF 8141-30-106, Depuy Orthopaedics, Inc.Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 12 hole, Sterile, REF 8141-30-112, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF 8141-30-115, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 18 hole, Sterile, REF 8141-30-118, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 18 hole, Sterile, REF 8141-31-118, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF 8141-30-109, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.