510(k) K954053 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
BERLIN EXTERNAL FIXATOR
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, May 16, 1996 |
| Received | Aug 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954053
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.