Product Code: MQN FDA class 2 21 CFR 872.4760

External Mandibular Fixator And/Or Distractor

Dental

The External Mandibular Fixator and/or Distractor is a dental implant device used externally to stabilize jaw fractures or to gradually distract (lengthen) the mandible through the process of distraction osteogenesis in patients with jaw deformities or after tumor resection. Classified as FDA Class 2 under 21 CFR 872.4760 in the Dental specialty, it requires 510(k) premarket notification. The product code is MQN, and it carries an implant flag.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MQN
Device Class: FDA class 2
Regulation Number: 872.4760
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220050	KLS Martin IPS Distraction	Aug 11, 2022	Substantially Equivalent	KLS Martin L.P.
K183113	DePuy Synthes Maxillofacial Portfolio - MR Conditional	Mar 13, 2019	Substantially Equivalent	Synthes (USA) Products, LLC
K181504	Stryker Pediatric Mandibular Distractor 2	Sep 11, 2018	Substantially Equivalent	Stryker
K162594	Craniomaxillofacial Distraction System (CMFD)	May 08, 2017	Substantially Equivalent	Synthes USA Products, LLC
K161470	Internal Distraction - Sterile	Dec 01, 2016	Substantially Equivalent	KLS Martin L.P.
K143285	Mandible External Fixator - MR Conditional	May 28, 2015	Substantially Equivalent	Synthes USA Products, LLC
K133398	STRYKER PEDIATRIC MANDIBLE DISTRACTOR	Mar 20, 2014	Substantially Equivalent	Stryker
K121502	SYNTHES CURVILINEAR DISTRACTION SYSTEM	Aug 23, 2012	Substantially Equivalent	Synthes, Inc.
K080458	MIS CREST WIDENER	Dec 17, 2008	Substantially Equivalent	Mis - Implant Technologies , Ltd.
K080542	DISTRAX	Dec 15, 2008	Substantially Equivalent	John W. King
K080153	SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM	May 14, 2008	Substantially Equivalent	Synthes (Usa)
K072764	KLS MARTIN XTERNAL FIXATOR	Dec 20, 2007	Substantially Equivalent	KLS Martin L.P.
K071628	STRYKER EXTERNAL FIXATION SYSTEM	Aug 10, 2007	Substantially Equivalent	Stryker Cmf
K062572	CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE	May 11, 2007	Substantially Equivalent	Custom Scientific
K063792	OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM	Mar 02, 2007	Substantially Equivalent	Osteomed LP
K062851	OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED	Nov 17, 2006	Substantially Equivalent	Osteomed LP
K062299	SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT	Aug 31, 2006	Substantially Equivalent	Synthes (Usa)
K060138	SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM	Jun 02, 2006	Substantially Equivalent	Synthes (Usa)
K051946	MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM	Aug 22, 2005	Substantially Equivalent	Medartis, Inc.
K043555	SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR	Apr 12, 2005	Substantially Equivalent	Synthes (Usa)
K050378	SYNTHES MANDIBLE EXTERNAL FIXATOR	Mar 15, 2005	Substantially Equivalent	Synthes (Usa)
K043434	OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM	Feb 10, 2005	Substantially Equivalent	Osteomed LP
K042278	ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)	Jan 28, 2005	Substantially Equivalent	Oral Osteodistraction, L.P.
K040169	SYNTHES MANDIBLE EXTERNAL FIXATOR	Apr 14, 2004	Substantially Equivalent	Synthes (Usa)
K040083	SYNTHES EXTERNAL MIDFACE DISTRACTOR	Mar 31, 2004	Substantially Equivalent	Synthes (Usa)
K034045	ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4	Mar 23, 2004	Substantially Equivalent	Oral Osteodistraction, L.P.
K034027	KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM	Feb 27, 2004	Substantially Equivalent	KLS-Martin L.P.
K030485	NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR	Dec 03, 2003	Substantially Equivalent	Newmedical Technology, Inc.
K031708	OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM	Nov 03, 2003	Substantially Equivalent	Osteomed LP
K033065	SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES	Oct 29, 2003	Substantially Equivalent	Synthes (Usa)
K032442	KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II	Oct 29, 2003	Substantially Equivalent	KLS-Martin L.P.
K030790	OSTEOMED ALVEOLAR DISTRACTION SYSTEM	Sep 10, 2003	Substantially Equivalent	Osteomed LP
K031696	LORENZE EXTERNAL MANDIBULAR DISTRACTOR	Jun 17, 2003	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K014001	DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3	Feb 04, 2003	Substantially Equivalent	Oral Osteodistraction, L.P.
K013618	INTRAORAL MANDIBULAR DISTRACTION SYSTEM	Aug 14, 2002	Substantially Equivalent	Osteomed Corp.
K020407	LORENZ BLUE DEVICE	Feb 22, 2002	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K010139	ZURICH DISTRACTION SYSTEM	Jun 29, 2001	Substantially Equivalent	KLS-Martin L.P.
K002152	TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION	Oct 10, 2000	Substantially Equivalent	KLS-Martin L.P.
K000580	ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15	Jul 24, 2000	Substantially Equivalent	KLS-Martin L.P.
K000992	MACROPOREDX DISTRACTOR SYSTEM	Jun 26, 2000	Substantially Equivalent	Macropore Biosurgery, Inc.
K993869	INTER-OS BONE GENERATOR	Jan 19, 2000	Substantially Equivalent	Inter-Os Technologies, LLC
K992952	LORENZ DISTRACTION SYSTEM	Nov 19, 1999	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K992873	LORENZ EXTERNAL MANDIBULAR DISTRACTOR	Sep 17, 1999	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K991875	K-L-W INTRAORAL DISTRACTOR	Aug 18, 1999	Substantially Equivalent	KLS-Martin L.P.
K990944	OSTEOMED INTRAORAL DISTRACTION SYSTEM	Jun 16, 1999	Substantially Equivalent	Osteomed Corp.
K984117	INNOVA TELESCOPIC DISTRACTOR	Feb 10, 1999	Substantially Equivalent	Innova Corp.
K983809	KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR	Jan 26, 1999	Substantially Equivalent	KLS-Martin L.P.
K983515	KLS INTRAORAL VERTICAL DISTRACTOR	Nov 30, 1998	Substantially Equivalent	KLS-Martin L.P.
K982906	LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM	Nov 12, 1998	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K982604	LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM	Oct 23, 1998	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K981275	SYNTHES (USA) RATCHETING DISTRACTOR	Jun 25, 1998	Substantially Equivalent	Synthes (Usa)
K981075	SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET	Jun 22, 1998	Substantially Equivalent	Synthes (Usa)
K973275	KLS-MARTIN INTRAORAL DISTRACTOR	Nov 20, 1997	Substantially Equivalent	KLS-Martin L.P.
K973018	SYNTHES MINI LENGTHENING APPARATUS	Nov 10, 1997	Substantially Equivalent	Synthes (Usa)
K972047	KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE	Jun 24, 1997	Substantially Equivalent	KLS-Martin L.P.
K962272	SYNTHES MANDIBLE DISTRACTOR	Aug 30, 1996	Substantially Equivalent	Synthes (Usa)
K960297	MANDIBULAR BONE DISTRACTOR II	Aug 06, 1996	Substantially Equivalent	Howmedica Corp.
K955640	LORENZ MANDIBULAR DISTRACTOR	Feb 14, 1996	Substantially Equivalent	Biomet, Inc.
K952847	NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR	Feb 06, 1996	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K945674	MANDIBULAR BONE DISTRACTOR	Jun 02, 1995	Substantially Equivalent	Howmedica Corp.