ClearanceBrief
Panels › Orthopedic › Product code LXT · Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Regulation 888.3030

0510(k)s in 12 months (57 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
Get daily alerts for LXTSample briefCSV

Top companies in LXT

Company510(k)sRecalls
Synthes (Usa)140
Howmedica Osteonics90
Zimmer Inc.07
Hand Innovations, Inc.60
Immedica, Inc.51
Biomet32
Encore Orthopedics, Inc.20
Zimmer Biomet, Inc.02
A.M. Surgical, Inc.10
Ace Medical Co.10
DateFirm and productCodeLinked 510(k)
Jun 28, 2022CHANGZHOU 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		 LXTK050932
Nov 20, 2018Zimmer 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		 LXTK112345
Nov 20, 2018Zimmer 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		 LXTK112345
Mar 8, 2016Biomet, 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		 LXTK112345
K132704 +2
Apr 14, 2015Biomet, 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		 LXTK112345
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-67. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-65. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Jun 30, 2009Zimmer Inc.
TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx
Terminated		 LXTK003205
K984357 +2
Feb 26, 2008Orthofix, 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		 LXTK941048
Jun 5, 2003Immedica Inc
TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.
Terminated		 LXTK990848

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.