FDA 510(k) Applications for Medical Device Product Code "MQN"
(External Mandibular Fixator And/Or Distractor)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K952847 | ACE SURGICAL SUPPLY CO., INC. | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | 02/06/1996 |
| K955640 | BIOMET, INC. | LORENZ MANDIBULAR DISTRACTOR | 02/14/1996 |
| K062572 | CUSTOM SCIENTIFIC | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | 05/11/2007 |
| K960297 | HOWMEDICA CORP. | MANDIBULAR BONE DISTRACTOR II | 08/06/1996 |
| K984117 | INNOVA CORP. | INNOVA TELESCOPIC DISTRACTOR | 02/10/1999 |
| K993869 | INTER-OS TECHNOLOGIES, L.L.C. | INTER-OS BONE GENERATOR | 01/19/2000 |
| K080542 | JOHN W. KING | DISTRAX | 12/15/2008 |
| K220050 | KLS Martin L.P. | KLS Martin IPS Distraction | 08/11/2022 |
| K072764 | KLS MARTIN L.P. | KLS MARTIN XTERNAL FIXATOR | 12/20/2007 |
| K161470 | KLS MARTIN LP | Internal Distraction - Sterile | 12/01/2016 |
| K991875 | KLS-MARTIN L.P. | K-L-W INTRAORAL DISTRACTOR | 08/18/1999 |
| K983515 | KLS-MARTIN L.P. | KLS INTRAORAL VERTICAL DISTRACTOR | 11/30/1998 |
| K034027 | KLS-MARTIN L.P. | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | 02/27/2004 |
| K983809 | KLS-MARTIN L.P. | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | 01/26/1999 |
| K973275 | KLS-MARTIN L.P. | KLS-MARTIN INTRAORAL DISTRACTOR | 11/20/1997 |
| K032442 | KLS-MARTIN L.P. | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | 10/29/2003 |
| K972047 | KLS-MARTIN L.P. | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | 06/24/1997 |
| K002152 | KLS-MARTIN L.P. | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION | 10/10/2000 |
| K010139 | KLS-MARTIN L.P. | ZURICH DISTRACTION SYSTEM | 06/29/2001 |
| K000580 | KLS-MARTIN L.P. | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 | 07/24/2000 |
| K000992 | MACROPORE BIOSURGERY, INC. | MACROPOREDX DISTRACTOR SYSTEM | 06/26/2000 |
| K051946 | MEDARTIS, INC. | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | 08/22/2005 |
| K080458 | MIS - IMPLANT TECHNOLOGIES LTD. | MIS CREST WIDENER | 12/17/2008 |
| K030485 | NEWMEDICAL TECHNOLOGY, INC. | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | 12/03/2003 |
| K014001 | ORAL OSTEODISTRACTION, L.P. | DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 | 02/04/2003 |
| K034045 | ORAL OSTEODISTRACTION, L.P. | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 | 03/23/2004 |
| K042278 | ORAL OSTEODISTRACTION, L.P. | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) | 01/28/2005 |
| K013618 | OSTEOMED CORP. | INTRAORAL MANDIBULAR DISTRACTION SYSTEM | 08/14/2002 |
| K990944 | OSTEOMED CORP. | OSTEOMED INTRAORAL DISTRACTION SYSTEM | 06/16/1999 |
| K030790 | OSTEOMED L.P. | OSTEOMED ALVEOLAR DISTRACTION SYSTEM | 09/10/2003 |
| K063792 | OSTEOMED L.P. | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | 03/02/2007 |
| K031708 | OSTEOMED L.P. | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM | 11/03/2003 |
| K043434 | OSTEOMED L.P. | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM | 02/10/2005 |
| K062851 | OSTEOMED L.P. | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | 11/17/2006 |
| K133398 | Stryker | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | 03/20/2014 |
| K181504 | Stryker | Stryker Pediatric Mandibular Distractor 2 | 09/11/2018 |
| K071628 | STRYKER CMF | STRYKER EXTERNAL FIXATION SYSTEM | 08/10/2007 |
| K981075 | SYNTHES (USA) | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET | 06/22/1998 |
| K060138 | SYNTHES (USA) | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | 06/02/2006 |
| K080153 | SYNTHES (USA) | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | 05/14/2008 |
| K981275 | SYNTHES (USA) | SYNTHES (USA) RATCHETING DISTRACTOR | 06/25/1998 |
| K033065 | SYNTHES (USA) | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES | 10/29/2003 |
| K043555 | SYNTHES (USA) | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | 04/12/2005 |
| K040083 | SYNTHES (USA) | SYNTHES EXTERNAL MIDFACE DISTRACTOR | 03/31/2004 |
| K962272 | SYNTHES (USA) | SYNTHES MANDIBLE DISTRACTOR | 08/30/1996 |
| K040169 | SYNTHES (USA) | SYNTHES MANDIBLE EXTERNAL FIXATOR | 04/14/2004 |
| K050378 | SYNTHES (USA) | SYNTHES MANDIBLE EXTERNAL FIXATOR | 03/15/2005 |
| K973018 | SYNTHES (USA) | SYNTHES MINI LENGTHENING APPARATUS | 11/10/1997 |
| K062299 | SYNTHES (USA) | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | 08/31/2006 |
| K183113 | Synthes (USA) Products LLC | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 03/13/2019 |
| K121502 | SYNTHES INC | SYNTHES CURVILINEAR DISTRACTION SYSTEM | 08/23/2012 |
| K162594 | SYNTHES USA PRODUCTS, LLC | Craniomaxillofacial Distraction System (CMFD) | 05/08/2017 |
| K143285 | Synthes USA Products, LLC | Mandible External Fixator - MR Conditional | 05/28/2015 |
| K020407 | WALTER LORENZ SURGICAL, INC. | LORENZ BLUE DEVICE | 02/22/2002 |
| K992952 | WALTER LORENZ SURGICAL, INC. | LORENZ DISTRACTION SYSTEM | 11/19/1999 |
| K992873 | WALTER LORENZ SURGICAL, INC. | LORENZ EXTERNAL MANDIBULAR DISTRACTOR | 09/17/1999 |
| K982906 | WALTER LORENZ SURGICAL, INC. | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM | 11/12/1998 |
| K982604 | WALTER LORENZ SURGICAL, INC. | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM | 10/23/1998 |
| K031696 | WALTER LORENZ SURGICAL, INC. | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | 06/17/2003 |
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