510(k) K071639 ยท HWC Screw, Fixation, Bone
QWIX POSITIONING SCREW
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Jul 9, 2007 |
| Received | Jun 15, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2016 | Integra LifeSciences Corp. Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only,
Product Usage: The QWIX Positioning 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.