510(k) K083843 ยท HRS Plate, Fixation, Bone
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2020 | Biomet A.L.P.S. T15 LOW PROFILE CORTICAL SCREW
3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the no Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.