510(k) K031219 ยท HSB Rod, Fixation, Intramedullary And Accessories
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
| Applicant | Orthofix, Inc., Mckinney TX, US |
| Decision | Substantially Equivalent, May 28, 2003 |
| Received | Apr 17, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031219
| 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.