FDA.reportPublic FDA data

Implantable craniofacial bone distractor

Definition
A non-powered implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
GUDID devices
147
Last updated
2026-07-17 22:00:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10887587015309NASynthes GmbH04.307.0082015-09-14
10887587016450NASynthes GmbH04.500.0002015-09-14
10887587040820NASynthes GmbH390.1002015-09-14
10887587040837NASynthes GmbH390.1022015-09-14
10887587040899NASynthes GmbH390.1202015-09-14
00888118144249DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-302-30-712026-04-23
00888118147059DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-303-30-712026-04-23
00888118147127DISTRACTION, INTERNALKLS-Martin L.P.51-302-30-092026-04-23
00888118153043DISTRACTION, INTERNALKLS-Martin L.P.51-303-30-092026-04-23
04046826129262MediconMedicon eG. Chirurgiemechaniker-Genossenschaft69.00.302020-09-24
10887587001432NASynthes GmbHSD288.0382015-09-14
10887587001449NASynthes GmbHSD288.0392015-09-14
10887587001456NASynthes GmbHSD288.0422015-09-14
10887587001463NASynthes GmbHSD288.0432015-09-14
10887587005362NASYNTHES (U.S.A.) LPSD487.9412015-09-14
10887587005379NASYNTHES (U.S.A.) LPSD487.9422015-09-14
10887587010083NASynthes GmbH03.307.0022015-09-14
10887587015316NASynthes GmbH04.307.1082015-09-14
10887587015323NASynthes GmbH04.307.1112015-09-14
10887587015330NASynthes GmbH04.315.0002015-09-14
10887587015347NASynthes GmbH04.315.0012015-09-14
10887587015361NASynthes GmbH04.315.0032015-09-14
10887587015378NASynthes GmbH04.315.0042015-09-14
10887587015385NASynthes GmbH04.315.0052015-09-14
10887587015392NASynthes GmbH04.315.0062015-09-14
10887587015439NASynthes GmbH04.315.0232015-09-14
10887587015446NASynthes GmbH04.315.0242015-09-14
10887587015453NASynthes GmbH04.315.0252015-09-14
10887587015460NASynthes GmbH04.315.0262015-09-14
10887587015477NASynthes GmbH04.315.0272015-09-14
10887587015484NASynthes GmbH04.315.0282015-09-14
10887587015507NASynthes GmbH04.315.0532015-09-14
10887587015514NASynthes GmbH04.315.0542015-09-14
10887587015521NASynthes GmbH04.315.0552015-09-14
10887587015538NASynthes GmbH04.315.0562015-09-14
10887587015576NASynthes GmbH04.315.0632015-09-14
10887587015583NASynthes GmbH04.315.0642015-09-14
10887587015590NASynthes GmbH04.315.0652015-09-14
10887587015606NASynthes GmbH04.315.0662015-09-14
10887587015613NASynthes GmbH04.315.0672015-09-14
10887587015620NASynthes GmbH04.315.0682015-09-14
10887587015736NASynthes GmbH04.315.2012015-09-14
10887587015743NASynthes GmbH04.315.2022015-09-14
10887587015750NASynthes GmbH04.315.2032015-09-14
10887587015767NASYNTHES (U.S.A.) LP04.315.2112015-09-14
10887587015774NASYNTHES (U.S.A.) LP04.315.2122015-09-14
10887587015781NASYNTHES (U.S.A.) LP04.315.2132015-09-14
10887587015798NASynthes GmbH04.315.3012015-09-14
10887587015804NASynthes GmbH04.315.3022015-09-14
10887587015811NASynthes GmbH04.315.3032015-09-14
10887587015859NASynthes GmbH04.315.3112015-09-14
10887587015866NASynthes GmbH04.315.3122015-09-14
10887587015873NASynthes GmbH04.315.3132015-09-14
10887587015880NASynthes GmbH04.315.3212015-09-14
10887587015897NASynthes GmbH04.315.3222015-09-14
10887587015903NASynthes GmbH04.315.3232015-09-14
10887587016139NASynthes GmbH04.315.4012015-09-14
10887587016146NASynthes GmbH04.315.4022015-09-14
10887587016153NASynthes GmbH04.315.4032015-09-14
10887587016160NASynthes GmbH04.315.4112015-09-14
10887587016177NASynthes GmbH04.315.4122015-09-14
10887587016184NASynthes GmbH04.315.4132015-09-14
10887587016191NASynthes GmbH04.315.4212015-09-14
10887587016207NASynthes GmbH04.315.4222015-09-14
10887587016214NASynthes GmbH04.315.4232015-09-14
10887587016221NASynthes GmbH04.315.5012015-09-14
10887587016238NASynthes GmbH04.315.5022015-09-14
10887587016245NASynthes GmbH04.315.5032015-09-14
10887587016283NASynthes GmbH04.315.5112015-09-14
10887587016290NASynthes GmbH04.315.5122015-09-14
10887587016306NASynthes GmbH04.315.5132015-09-14
10887587016467NASynthes GmbH04.500.0012015-09-14
10887587016573NASynthes GmbH04.500.0182015-09-14
10887587016702NASynthes GmbH04.500.1002015-09-14
10887587016719NASynthes GmbH04.500.1012015-09-14
10887587016733NASynthes GmbH04.500.1302015-09-14
10887587016740NASynthes GmbH04.500.1312015-09-14
10887587016757NASynthes GmbH04.500.1402015-09-14
10887587016764NASynthes GmbH04.500.1412015-09-14
10887587016771NASynthes GmbH04.500.1502015-09-14