510(k) K090596 ยท HSB Rod, Fixation, Intramedullary And Accessories
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 30, 2009 |
| Received | Mar 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Various fixation systems and accessories, Item Nos. 00118100522
00118100527
00118100530
00118100532
00118100535
00118100537
00118100540
00118100542
00118100550
00118100552
00118100562
00118100565
0011 Terminated |
KTT | None listed |
| Mar 28, 2011 | Stryker Howmedica Osteonics Corp. Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill);
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
The Triathlon Terminated |
None listed | |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00.
The device is used to drill into the proximal tibia or distal femur Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05.
The device is used to drill into the proximal tibia or distal femur for Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10.
The device is used to drill into the proximal tibia or Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00.
The device is used to drill into the proximal tibia or distal femur for placement Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03.
The device is used to drill into the proximal tibia or distal femur for placement Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-00.
The device is used to drill into the proximal tibia or distal femur fo Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-10.
The device is used to drill into the proximal tibia or di Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-03.
The device is used to drill into the proximal tibia or distal femur for p Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-08.
The device is used to drill into the proximal tibia or distal femur for place Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-53.
The device is used to drill into the proximal tibia or distal femur for place Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-03.
The device is used to drill into the proximal tibia or distal femur for plac Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-08.
The device is used to drill into the proximal tibia or distal femur for placemen Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-04.
The device is used to drill into the proximal tibia or distal femur for placement of screws that stabili Terminated |
HSB | None listed |
| Nov 24, 2009 | Zimmer Inc. Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11.
The device is used to drill into the proximal tibia or distal femur for placement of screws that stabi Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.