510(k) K142442 ยท HWC Screw, Fixation, Bone
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 3, 2014 |
| Received | Sep 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020
Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bon Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 44 consists of all product under product code: HWC and same usage:
Item no:
114607099 MAGMA-FX CANN SCREW 7.0MM
114604099 MAGNA FX CANN SCREW 7.0MM
114603000 MAGNA-FX CANN SCREW 7.0MM
114603 Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 46 consists of all product under product code: HWC and same usage:
Item no:
114204012 MINI MAGNA-FX CANN SCREW
114204016 MINI MAGNA-FX CANN SCREW
114204020 MINI MAGNA-FX CANN SCREW
114204024 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.