Product code LXT— Orthopedic
SHOULDER FIXATION SYSTEM
- Classification name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 57
- First cleared
- Most recent
Market context for product code LXT
FDA has cleared devices under product code LXT between 1986 and 2023, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2013
- 2011
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
Top applicants under product code LXT
Recent clearances under product code LXT
- K230067 — Para-Fix External Fixation System
- K131636 — POLARUS CONNECT
- K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
- K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS
- K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
- K073135 — SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
- K063832 — SYNTHES (USA) ELBOW HINGE FIXATOR
- K060864 — MULTIDIRECTIONAL THREADED PEG
- K060403 — PTA (PROGRESSIVE TIBIAL ALIGNMENT)
- K060290 — SHOULDER FIXATION SYSTEM
- K052754 — WRIST FUSION PLATE
- K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM
- K051306 — HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
- K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
- K050631 — SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
- K042458 — A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
- K042059 — SHOULDER FIXATION SYSTEM
- K033805 — SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
- K033145 — HOFFMANN II PELVIC CLAMP
- K032705 — DISTAL RADIUS FRACTURE REPAIR SYSTEM
- K032169 — CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
- K031973 — SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
- K031428 — SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
- K031959 — STRYKER PLATING SYSTEM PERIARTICULAR PLATES
- K030390 — SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
- K022651 — HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
- K020905 — NBX - NON-BRIDGING EXTERNAL FIXATOR
- K013739 — MODIFICATION TO EBI XFIX DFS SYSTEM
- K013772 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K011948 — HOFFMAN II HYBRID RING CLAMP
- K003240 — BIOMET EXTERNAL WRIST PLATE
- K002923 — DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
- K003205 — TRANSFX ANGLED RODS
- K003211 — HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
- K001760 — RADIOLUCENT COLLES FRACTURE KIT
- K001793 — SYNTHES SCALLOPED DISTAL TIBIA PLATE
- K000972 — SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
- K001084 — TRANS FX ADJUSTABLE PIN TO BAR CLAMP
- K000957 — HOFFMANN II EXTERNAL FIXATION SYSTEM
- K000558 — SYNTHES (USA) WRIST FUSION PLATES (WFP)
- K991889 — ULTIMAX HAIG II NAIL SYSTEM
- K991723 — TRANSFX MULTI PIN CLAMP
- K991407 — SYNTHES LOCKING CALCANEAL PLATES
- K990848 — TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
- K984357 — TRANSFX EXTERNAL FIXATION SYSTEM
- K974245 — DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
- K963432 — GUIDE WIRES FOR CANNULATED SCREWS
- K963618 — SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
- K962846 — EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
- K954053 — BERLIN EXTERNAL FIXATOR
- K960269 — TITANIUM UNIVERSAL CLAMP
- K955388 — ACE-DUPONT COMPOSITE RINGS
- K953397 — HEX-FIX FIELD FIXATOR
- K950384 — SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
- K941048 — TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
- K874377 — ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
- K864403 — MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.