510(k) K201918 ยท HRS Plate, Fixation, Bone
EVOS Large Fragment Plating System
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 16, 2020 |
| Received | Jul 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201918
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2021 | Smith & Nephew, Inc. smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Terminated |
HRS | None listed |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Terminated |
HRS | None listed |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Terminated |
HRS | None listed |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.