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 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 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 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 Apr 14, 2004
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169
Synthes (Usa)
Dental · 79d
Cleared Mar 31, 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083
Synthes (Usa)
Dental · 76d
Cleared Feb 27, 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027
KLS-Martin L.P.
Dental · 60d
Cleared Oct 29, 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442
KLS-Martin L.P.
Dental · 82d
Cleared Oct 29, 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065
Synthes (Usa)
Dental · 30d
Cleared Jun 17, 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696
Walter Lorenz Surgical, Inc.
Dental · 15d
Cleared Feb 22, 2002
LORENZ BLUE DEVICE
K020407
Walter Lorenz Surgical, Inc.
Dental · 16d
Cleared Jun 29, 2001
ZURICH DISTRACTION SYSTEM
K010139
KLS-Martin L.P.
Dental · 163d
Cleared Oct 10, 2000
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152
KLS-Martin L.P.
Dental · 85d
Cleared Jul 24, 2000
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580
KLS-Martin L.P.
Dental · 153d
Cleared Nov 19, 1999
LORENZ DISTRACTION SYSTEM
K992952
Walter Lorenz Surgical, Inc.
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.