510(k) K050346 ยท HWC Screw, Fixation, Bone
STABILIZATION SCREW
| Applicant | New Deal, S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, Mar 17, 2005 |
| Received | Feb 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2010 | Integra LifeSciences Corporation Qwix 4.3mm Stabilization Screws - 32mm Terminated |
HWC | None listed |
| Apr 7, 2010 | Integra LifeSciences Corporation Qwix 4.3mm Stabilization Screws - 34mm Terminated |
HWC | None listed |
| Aug 15, 2008 | Integra LifeSciences Corp. QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. Terminated |
HWC | None listed |
| Aug 15, 2008 | Integra LifeSciences Corp. QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.