510(k) K941048 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
| Applicant | Applied Osteo Systems, Inc., Walnut Creek CA, US |
| Decision | Substantially Equivalent, Oct 3, 1994 |
| Received | Mar 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941048
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2008 | Orthofix, Inc Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 5 Terminated |
LXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.