510(k) K151010 ยท HSB Rod, Fixation, Intramedullary And Accessories
Piccolo Composite Nailing System
| Applicant | CarboFix Orthopedics , Ltd., Herzliya, IL |
| Decision | Substantially Equivalent, Jul 28, 2015 |
| Received | Apr 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151010
| 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.