510(k) K153536 · HSB Rod, Fixation, Intramedullary And Accessories
Piccolo Composite® Nailing System
| Applicant | CarboFix Orthopedics , Ltd., Herzeliya, IL |
| Decision | Substantially Equivalent, Jan 6, 2016 |
| Received | Dec 10, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2016 | CarboFix Orthopedics, Ltd. Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.