510(k) K000083 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
EBI XFIX DFS RAIL SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Feb 3, 2000 |
| Received | Jan 12, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2012 | Biomet, Inc. EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.