510(k) K021932 ยท HWC Screw, Fixation, Bone
SYNTHES 6.5 MM CANNULATED SCREW
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Sep 6, 2002 |
| Received | Jun 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2016 | Synthes (USA) Products LLC 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral n Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral n Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such a Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as f Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral neck Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such Terminated |
HWC | None listed |
| Jul 11, 2016 | Synthes (USA) Products LLC 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such a Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.