510(k) K140814 ยท HRS Plate, Fixation, Bone
EVOS MINI-FRAGMENT PLATING SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 7, 2014 |
| Received | Apr 1, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2020 | Smith & Nephew, Inc. EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. Terminated |
HRS | None listed |
| Nov 29, 2017 | Smith & Nephew, Inc. smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116
Bone plates and bone screws from the EVOS Mini-Fragme Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.