510(k) K112345 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
DISTAL VOLAR RADIUS PLATING SYSTEMS
| Applicant | Medos International SARL, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 31, 2011 |
| Received | Aug 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2018 | Zimmer Biomet, Inc. Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile
ITEM 131827120
Product Usage:
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures Terminated |
LXT | None listed |
| Nov 20, 2018 | Zimmer Biomet, Inc. Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile
ITEM 131827118
Product Usage: Usage:
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision pro Terminated |
LXT | None listed |
| Mar 8, 2016 | Biomet, Inc. Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation
The Cross lock DVR ePAK Volar Rim Plates system is intended for Terminated |
LXT | None listed |
| Apr 14, 2015 | Biomet, Inc. LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222;
LOT RM105E.
Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive s Terminated |
LXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.