Atlas FDA

MQN

60 FDA 510(k) clearances · Product code

88 daysmedian time to decision
253 days90th percentile
60clearances measured

FDA profile

Official device name
External Mandibular Fixator And/Or Distractor
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4760
Medical specialty
Dental
Flags
Implant
Adverse events (MAUDE)
2021: 101 · 2022: 61 · 2023: 39 · 2024: 60 · 2025: 35 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KLS Martin IPS Distraction (K220050)KLS Martin L.P.2022-08-11
DePuy Synthes Maxillofacial Portfolio - MR Conditional (K183113)Synthes (USA) Products, LLC2019-03-13
Stryker Pediatric Mandibular Distractor 2 (K181504)Stryker2018-09-11
Craniomaxillofacial Distraction System (CMFD) (K162594)Synthes USA Products, LLC2017-05-08
Internal Distraction - Sterile (K161470)KLS Martin L.P.2016-12-01
Mandible External Fixator - MR Conditional (K143285)Synthes USA Products, LLC2015-05-28
STRYKER PEDIATRIC MANDIBLE DISTRACTOR (K133398)Stryker2014-03-20
SYNTHES CURVILINEAR DISTRACTION SYSTEM (K121502)Synthes, Inc.2012-08-23
MIS CREST WIDENER (K080458)Mis - Implant Technologies , Ltd.2008-12-17
DISTRAX (K080542)John W. King2008-12-15
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (K080153)Synthes (Usa)2008-05-14
KLS MARTIN XTERNAL FIXATOR (K072764)KLS Martin L.P.2007-12-20
STRYKER EXTERNAL FIXATION SYSTEM (K071628)Stryker Cmf2007-08-10
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE (K062572)Custom Scientific2007-05-11
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM (K063792)Osteomed LP2007-03-02
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED (K062851)Osteomed LP2006-11-17
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT (K062299)Synthes (Usa)2006-08-31
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM (K060138)Synthes (Usa)2006-06-02
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM (K051946)Medartis, Inc.2005-08-22
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR (K043555)Synthes (Usa)2005-04-12
SYNTHES MANDIBLE EXTERNAL FIXATOR (K050378)Synthes (Usa)2005-03-15
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM (K043434)Osteomed LP2005-02-10
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) (K042278)Oral Osteodistraction, L.P.2005-01-28
SYNTHES MANDIBLE EXTERNAL FIXATOR (K040169)Synthes (Usa)2004-04-14
SYNTHES EXTERNAL MIDFACE DISTRACTOR (K040083)Synthes (Usa)2004-03-31
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 (K034045)Oral Osteodistraction, L.P.2004-03-23
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM (K034027)KLS-Martin L.P.2004-02-27
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (K030485)Newmedical Technology, Inc.2003-12-03
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM (K031708)Osteomed LP2003-11-03
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II (K032442)KLS-Martin L.P.2003-10-29
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES (K033065)Synthes (Usa)2003-10-29
OSTEOMED ALVEOLAR DISTRACTION SYSTEM (K030790)Osteomed LP2003-09-10
LORENZE EXTERNAL MANDIBULAR DISTRACTOR (K031696)Walter Lorenz Surgical, Inc.2003-06-17
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 (K014001)Oral Osteodistraction, L.P.2003-02-04
INTRAORAL MANDIBULAR DISTRACTION SYSTEM (K013618)Osteomed Corp.2002-08-14
LORENZ BLUE DEVICE (K020407)Walter Lorenz Surgical, Inc.2002-02-22
ZURICH DISTRACTION SYSTEM (K010139)KLS-Martin L.P.2001-06-29
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION (K002152)KLS-Martin L.P.2000-10-10
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 (K000580)KLS-Martin L.P.2000-07-24
MACROPOREDX DISTRACTOR SYSTEM (K000992)Macropore Biosurgery, Inc.2000-06-26
INTER-OS BONE GENERATOR (K993869)Inter-Os Technologies, LLC2000-01-19
LORENZ DISTRACTION SYSTEM (K992952)Walter Lorenz Surgical, Inc.1999-11-19
LORENZ EXTERNAL MANDIBULAR DISTRACTOR (K992873)Walter Lorenz Surgical, Inc.1999-09-17
K-L-W INTRAORAL DISTRACTOR (K991875)KLS-Martin L.P.1999-08-18
OSTEOMED INTRAORAL DISTRACTION SYSTEM (K990944)Osteomed Corp.1999-06-16
INNOVA TELESCOPIC DISTRACTOR (K984117)Innova Corp.1999-02-10
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR (K983809)KLS-Martin L.P.1999-01-26
KLS INTRAORAL VERTICAL DISTRACTOR (K983515)KLS-Martin L.P.1998-11-30
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM (K982906)Walter Lorenz Surgical, Inc.1998-11-12
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM (K982604)Walter Lorenz Surgical, Inc.1998-10-23
SYNTHES (USA) RATCHETING DISTRACTOR (K981275)Synthes (Usa)1998-06-25
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET (K981075)Synthes (Usa)1998-06-22
KLS-MARTIN INTRAORAL DISTRACTOR (K973275)KLS-Martin L.P.1997-11-20
SYNTHES MINI LENGTHENING APPARATUS (K973018)Synthes (Usa)1997-11-10
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE (K972047)KLS-Martin L.P.1997-06-24
SYNTHES MANDIBLE DISTRACTOR (K962272)Synthes (Usa)1996-08-30
MANDIBULAR BONE DISTRACTOR II (K960297)Howmedica Corp.1996-08-06
LORENZ MANDIBULAR DISTRACTOR (K955640)Biomet, Inc.1996-02-14
NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR (K952847)Ace Surgical Supply Co., Inc.1996-02-06
MANDIBULAR BONE DISTRACTOR (K945674)Howmedica Corp.1995-06-02

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