510(k) K131657 ยท HRS Plate, Fixation, Bone
FLOWER SMALL AND MEDIUM IMPLANT SET
| Applicant | Flower Orthopedics Corporation, Philedelphia PA, US |
| Decision | Substantially Equivalent, Aug 22, 2013 |
| Received | Jun 6, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2015 | Flower Orthopedics Corporation Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.