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MQN — External Mandibular Fixator And/Or Distractor Class II

FDA Device Classification

Classification Details

Product Code
MQN
Device Class
Class II
Regulation Number
872.4760
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220050kls martin l.pKLS Martin IPS DistractionAugust 11, 2022
K183113synthes (usa) productsDePuy Synthes Maxillofacial Portfolio - MR ConditionalMarch 13, 2019
K181504strykerStryker Pediatric Mandibular Distractor 2September 11, 2018
K162594synthes usa productsCraniomaxillofacial Distraction System (CMFD)May 8, 2017
K161470kls martin l.pInternal Distraction - SterileDecember 1, 2016
K143285synthes usa productsMandible External Fixator - MR ConditionalMay 28, 2015
K133398strykerSTRYKER PEDIATRIC MANDIBLE DISTRACTORMarch 20, 2014
K121502synthesSYNTHES CURVILINEAR DISTRACTION SYSTEMAugust 23, 2012
K080458mis - implant technologiesMIS CREST WIDENERDecember 17, 2008
K080542john w. kingDISTRAXDecember 15, 2008
K080153synthes (usa)SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEMMay 14, 2008
K072764kls martin l.pKLS MARTIN XTERNAL FIXATORDecember 20, 2007
K071628stryker cmfSTRYKER EXTERNAL FIXATION SYSTEMAugust 10, 2007
K062572custom scientificCRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATEMay 11, 2007
K063792osteomedOSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMMarch 2, 2007
K062851osteomedOSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDEDNovember 17, 2006
K062299synthes (usa)SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KITAugust 31, 2006
K060138synthes (usa)SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEMJune 2, 2006
K051946medartisMODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEMAugust 22, 2005
K043555synthes (usa)SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTORApril 12, 2005