510(k) K083032 ยท HRS Plate, Fixation, Bone
PERI-LOC BONE PLATING AND SCREW SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 7, 2009 |
| Received | Oct 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2015 | Smith & Nephew, Inc. Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate Terminated |
HRS | None listed |
| Dec 4, 2015 | Smith & Nephew, Inc. Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.