510(k) K111447 ยท HWC Screw, Fixation, Bone
ZIMMER PERIARTICULAR SCREWS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 5, 2011 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length
47234702116 Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 7 consists of all products under product code HWC, and same usage:
Item no:
47234801435 3.5MM CORT SCR X 14MM
47234801635 3.5MM CORT SCR X 16MM
47234806535 3.5MM CORT SCR X 65MM
47234807035 Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 56 consists of all product under product code: HWC and same usage:
Item no:
47234702032 PERI SCR 3.5MM X 32MM STE
47234702018 PERI SCR. 3.5MM X 18MM ST
47234702020 PERI SCR. 3.5MM X 20MM ST
4 Terminated |
HWC | None listed |
| Aug 26, 2014 | Zimmer, Inc. Trauma Large Screws:
CANN BONE SCREW 7.0MMX100MMLG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0MMX105MMLG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.