510(k) K123562 ยท HRS Plate, Fixation, Bone
FLOWER SMALL AND MEDIUM BONE IMPLANTS
| Applicant | Flower Orthopedics Corporation, Philedelphia PA, US |
| Decision | Substantially Equivalent, Mar 29, 2013 |
| Received | Nov 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2021 | Flower Orthopedics Corporation Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Terminated |
HRS | None listed |
| 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.