510(k) K143321 ยท HSB Rod, Fixation, Intramedullary And Accessories
ITST Intertrochanteric/Subtrochanteric Fixation System
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 29, 2015 |
| Received | Nov 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 36 consists of all product under product code: HSB and same usage:
Item no:
225302745 INTERLOCKING IM SCREW 4.5
225303045 INTERLOCKING IM SCREW 4.5
225303245 INTERLOCKING IM SCREW 4.5
225303 Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.