510(k) K010322 ยท HSB Rod, Fixation, Intramedullary And Accessories
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
| Applicant | Orthodyne, Inc., Orlando FL, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Feb 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2013 | Orthofix, Inc Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor.
The ISKD is intended for limb lengthening of the tibia and femur. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.