510(k) K012967 ยท HSB Rod, Fixation, Intramedullary And Accessories
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
| Applicant | Disco-O-Tech Medical Technologies, Ltd., Herzlia, IL |
| Decision | Substantially Equivalent, Oct 4, 2001 |
| Received | Sep 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2003 | Disc Orthopaedic Technologies Inc Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion Terminated |
NDH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.