510(k) K110592 ยท HWC Screw, Fixation, Bone
3.7MM/5.0MM DYNAMIC LOCKING SCREW
| Applicant | Synthes USA, West Chester PA, US |
| Decision | Substantially Equivalent, Jul 25, 2011 |
| Received | Mar 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2015 | Synthes (USA) Products LLC Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixatio Terminated |
HWC | None listed |
| Nov 26, 2013 | Synthes USA HQ, Inc. 3.7mm and 5.0mm Dynamic Locking Screw (DLS)
Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bon Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.