SYNTHES (USA) ELBOW HINGE FIXATOR— 510(k) K063832

Name: FDA 510(k) clearance K063832
Creator: U.S. Food and Drug Administration
Published: 2007-03-07

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K063832 for SYNTHES (USA) ELBOW HINGE FIXATOR, Substantially Equivalent on 2007-03-07. Applicant: Synthes (Usa). Device class: 2.

Clearance details

Applicant: Synthes (Usa)
Product code: Code LXT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2006-12-26
Decision date: 2007-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXT

view all

K230067 — Para-Fix External Fixation System2023-09-22
K131636 — POLARUS CONNECT2013-10-10
K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW2013-10-09
K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS2011-10-31
K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S2009-03-11

More clearances from Synthes (Usa)

view all

K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM2015-03-30
K131984 — SYNTHES SYNSONIC ULNA NAIL2014-03-31
K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE2012-07-06
K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM2012-06-18
K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)2012-05-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.