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510(k) K183113

Device
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Applicant
Synthes (USA) Products LLC
510(k) number
K183113
Product code
MQN  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-13
Date received
2018-11-09
Regulation
872.4760
Classification name
External Mandibular Fixator And/or Distractor
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rebecca Reiter
Address
1301 Goshen Pkwy. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220050KLS Martin IPS DistractionKLS Martin L.P.2022-08-11
K181504Stryker Pediatric Mandibular Distractor 2Stryker2018-09-11
K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC2017-05-08
K161470Internal Distraction - SterileKLS Martin L.P.2016-12-01
K143285Mandible External Fixator - MR ConditionalSynthes USA Products, LLC2015-05-28
K133398STRYKER PEDIATRIC MANDIBLE DISTRACTORStryker2014-03-20
K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.2012-08-23
K080458MIS CREST WIDENERMis - Implant Technologies , Ltd.2008-12-17
K080542DISTRAXJohn W. King2008-12-15
K080153SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEMSynthes (Usa)2008-05-14
K072764KLS MARTIN XTERNAL FIXATORKLS Martin L.P.2007-12-20
K071628STRYKER EXTERNAL FIXATION SYSTEMStryker Cmf2007-08-10
K062572CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATECustom Scientific2007-05-11
K063792OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMOsteomed LP2007-03-02
K062851OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDEDOsteomed LP2006-11-17