510(k) K143165 ยท HWC Screw, Fixation, Bone
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 31, 2015 |
| Received | Nov 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507
Herbert Cannulated Bone Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 32 consists of all product under product code: HWC and same usage:
Item no:
47115401200 HERBERT BONE SCREW, 3.0MM
47115401400 HERBERT BONE SCREW, 3.0MM
47115401600 HERBERT BONE SCREW, 3.0MM
Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.