510(k) K984357 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
TRANSFX EXTERNAL FIXATION SYSTEM
| Applicant | Immedica, Inc., Chatham NJ, US |
| Decision | Substantially Equivalent, Mar 4, 1999 |
| Received | Dec 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-65. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
| Jun 30, 2009 | Zimmer Inc. TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-67. TransFx drill bits can be found in the following kits: TransFx Terminated |
LXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.