510(k) K132296 ยท HRS Plate, Fixation, Bone
D-RAD SMART PACK
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 7, 2014 |
| Received | Jul 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2018 | Smith & Nephew, Inc. D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R Terminated |
HWC | None listed |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816
Orthopedic Terminated |
HWC | None listed |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420
Orthopedic Terminated |
HWC | None listed |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes:
(a) 2.4MM X 10MM, RES 74692410
(b) 2.4MM X 12MM, RES 74692412
(c) 2.4MM X 16MM, RES 74692416
(d) 2.4MM X 22MM, RES 74692422 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.