MQN · Class II · 21 CFR 872.4760

FDA Product Code MQN: External Mandibular Fixator And/or Distractor

Leading manufacturers include KLS-Martin L.P., Synthes (Usa) and Walter Lorenz Surgical, Inc..

60
Total
60
Cleared
119d
Avg days
1995
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared External Mandibular Fixator And/or Distractor Devices (Product Code MQN)

60 devices
1–24 of 60
Cleared Aug 11, 2022
KLS Martin IPS Distraction
K220050
KLS-Martin L.P.
Dental · 217d
Cleared Mar 13, 2019
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113
Synthes USA Products, LLC
Dental · 124d
Cleared Sep 11, 2018
Stryker Pediatric Mandibular Distractor 2
K181504
Stryker
Dental · 96d
Cleared May 08, 2017
Craniomaxillofacial Distraction System (CMFD)
K162594
Synthes USA Products, LLC
Dental · 234d
Cleared Dec 01, 2016
Internal Distraction - Sterile
K161470
KLS-Martin L.P.
Dental · 188d
Cleared May 28, 2015
Mandible External Fixator - MR Conditional
K143285
Synthes USA Products, LLC
Dental · 192d
Cleared Mar 20, 2014
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398
Stryker
Dental · 134d
Cleared Aug 23, 2012
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502
Synthes, Inc.
Dental · 94d
Cleared Dec 17, 2008
MIS CREST WIDENER
K080458
Mis - Implant Technologies , Ltd.
Dental · 301d
Cleared Dec 15, 2008
DISTRAX
K080542
John W. King
Dental · 292d
Cleared May 14, 2008
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153
Synthes (Usa)
Dental · 112d
Cleared Dec 20, 2007
KLS MARTIN XTERNAL FIXATOR
K072764
KLS-Martin L.P.
Dental · 83d
Cleared Aug 10, 2007
STRYKER EXTERNAL FIXATION SYSTEM
K071628
Stryker Cmf
Dental · 57d
Cleared May 11, 2007
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
K062572
Custom Scientific
Dental · 253d
Cleared Mar 02, 2007
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792
Osteomed LP
Dental · 70d
Cleared Nov 17, 2006
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851
Osteomed LP
Dental · 53d
Cleared Aug 31, 2006
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299
Synthes (Usa)
Dental · 23d
Cleared Jun 02, 2006
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138
Synthes (Usa)
Dental · 134d
Cleared Aug 22, 2005
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
K051946
Medartis, Inc.
Dental · 35d
Cleared Apr 12, 2005
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555
Synthes (Usa)
Dental · 106d
Cleared Mar 15, 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378
Synthes (Usa)
Dental · 28d
Cleared Feb 10, 2005
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K043434
Osteomed LP
Dental · 59d
Cleared Jan 28, 2005
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
K042278
Oral Osteodistraction, L.P.
Dental · 158d
Cleared Apr 14, 2004
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169
Synthes (Usa)
Dental · 79d

About Product Code MQN - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code MQN since 1995, with 60 receiving FDA clearance (average review time: 119 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.