510(k) K083497 ยท HSB Rod, Fixation, Intramedullary And Accessories
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 19, 2009 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2017 | Zimmer Biomet, Inc. Z NAIL PF 14MM X 46CM UNIV
Z NAIL GT 14MM X 46CM R
Z NAIL GT 14MM X 46CM L
Z NAIL TIBIA 14MM X 38CM UNIV
Z NAIL TIBIA 14MM X 40CM UNIV
Z NAIL TIBIA 14MM X 42CM UNIV
Z NAIL TIBIA 14MM X 44CM UNIV Terminated |
HSB | None listed |
| Jul 13, 2015 | Zimmer, Inc. ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. Terminated |
HSB | 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.