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 Mar 31, 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083
Synthes (Usa)
Dental · 76d
Cleared Mar 23, 2004
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
K034045
Oral Osteodistraction, L.P.
Dental · 85d
Cleared Feb 27, 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027
KLS-Martin L.P.
Dental · 60d
Cleared Dec 03, 2003
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K030485
Newmedical Technology, Inc.
Dental · 292d
Cleared Nov 03, 2003
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
K031708
Osteomed LP
Dental · 154d
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 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 Feb 04, 2003
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
K014001
Oral Osteodistraction, L.P.
Dental · 427d
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