510(k) K142281 ยท HSB Rod, Fixation, Intramedullary And Accessories
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 22, 2014 |
| Received | Aug 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Various fixation systems and accessories, Item Nos. 00224000916
00224000918
00224000920
00224000922
00224000924
00224000926
00224000928
00224000930
00224000932
00224000934
00224000936
00224000938
0022 Terminated |
HSB | None listed |
| Apr 28, 2017 | Zimmer Biomet, Inc. R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM,
11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36C Terminated |
HSB | None listed |
| Apr 28, 2017 | Zimmer Biomet, Inc. TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM
TIBIAL I/M NAIL 15MMDX30CM
TIBIAL I/M NAIL 14MMDX32CM
TIBIAL I/M NAIL 15MMDX32CM
TIBIAL I/M NAIL 14MMDX34CM
TIBIAL I/M NAIL 15MMDX34CM
TIBI Terminated |
HSB | None listed |
| Apr 28, 2017 | Zimmer Biomet, Inc. FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT
FEM IM NAIL 13MMDX32CM LEFT
FEM IM NAIL 14MMDX32CM LEFT
FEM IM NAIL 13MMDX32CM RIGHT
FEM IM NAIL 14MMDX32CM RIGHT
FEM IM NAIL 11MMDX34CM Terminated |
HSB | None listed |
| May 16, 2016 | Zimmer Manufacturing B.V. M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 002253 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 38 consists of all product under product code: HSB and same usage:
Item no:
225303255 INTERLOCKING IM SCREW LG
225303555 INTERLOCKING IM SCREW LG
225303755 INTERLOCKING IM SCREW LG
225307055 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 43 consists of all product under product code: HSB and same usage:
Item no:
224001016 M/DN R-F IM NAIL 10MM DIA
224001018 M/DN R-F IM NAIL 10MM DIA
224001020 M/DN R-F IM NAIL 10MM DIA
224001 Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.