510(k) K050932 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
| Applicant | Hand Innovations, Inc., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Apr 26, 2005 |
| Received | Apr 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2022 | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. Terminated |
LXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.