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
60 devices
25–48 of 60
Cleared Sep 10, 2003
OSTEOMED ALVEOLAR DISTRACTION SYSTEM
K030790
Osteomed LP
Dental · 182d
Cleared Jun 17, 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696
Walter Lorenz Surgical, Inc.
Dental · 15d
Cleared Aug 14, 2002
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K013618
Osteomed Corp.
Dental · 282d
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 Jun 26, 2000
MACROPOREDX DISTRACTOR SYSTEM
K000992
Macropore Biosurgery, Inc.
Dental · 90d
Cleared Jan 19, 2000
INTER-OS BONE GENERATOR
K993869
Inter-Os Technologies, LLC
Dental · 65d
Cleared Nov 19, 1999
LORENZ DISTRACTION SYSTEM
K992952
Walter Lorenz Surgical, Inc.
Dental · 79d
Cleared Sep 17, 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873
Walter Lorenz Surgical, Inc.
Dental · 22d
Cleared Aug 18, 1999
K-L-W INTRAORAL DISTRACTOR
K991875
KLS-Martin L.P.
Dental · 77d
Cleared Jun 16, 1999
OSTEOMED INTRAORAL DISTRACTION SYSTEM
K990944
Osteomed Corp.
Dental · 86d
Cleared Feb 10, 1999
INNOVA TELESCOPIC DISTRACTOR
K984117
Innova Corp.
Dental · 85d
Cleared Jan 26, 1999
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809
KLS-Martin L.P.
Dental · 90d
Cleared Nov 30, 1998
KLS INTRAORAL VERTICAL DISTRACTOR
K983515
KLS-Martin L.P.
Dental · 54d
Cleared Nov 12, 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906
Walter Lorenz Surgical, Inc.
Dental · 86d
Cleared Oct 23, 1998
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
K982604
Walter Lorenz Surgical, Inc.
Dental · 88d
Cleared Jun 25, 1998
SYNTHES (USA) RATCHETING DISTRACTOR
K981275
Synthes (Usa)
Dental · 78d
Cleared Jun 22, 1998
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
K981075
Synthes (Usa)
Dental · 90d
Cleared Nov 20, 1997
KLS-MARTIN INTRAORAL DISTRACTOR
K973275
KLS-Martin L.P.
Dental · 79d
Cleared Nov 10, 1997
SYNTHES MINI LENGTHENING APPARATUS
K973018
Synthes (Usa)
Dental · 89d
Cleared Jun 24, 1997
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
K972047
KLS-Martin L.P.
Dental · 22d
Cleared Aug 30, 1996
SYNTHES MANDIBLE DISTRACTOR
K962272
Synthes (Usa)
Dental · 78d