FDA.report

510(k) K013618

Device
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
Applicant
Osteomed Corp.
510(k) number
K013618
Product code
MQN
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-14
Date received
2001-11-05
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
N

Related Records

Applicant Contact

Contact
DAWN T HOLDEMAN
Address
3750 Realty Rd. Addison TX US 75001 75001

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MQN

510(k)DeviceApplicantDecision date
K220050KLS Martin IPS DistractionKLS Martin L.P.2022-08-11
K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC2019-03-13
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