FDA.report

510(k) K043434

Device
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
Applicant
Osteomed LP
510(k) number
K043434
Product code
MQN
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-10
Date received
2004-12-13
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

Related Records

Applicant Contact

Contact
DAWN T HOLDEMAN
Address
3885 Arapaho Rd. Addison TX US 75001 75001

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC2017-05-08
K161470Internal Distraction - SterileKLS Martin L.P.2016-12-01
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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