External Mandibular Fixator And/Or Distractor
Regulation 872.4760
0510(k)s in 12 months (60 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in MQN
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 13 | 2 |
| KLS Martin L.P. | 13 | 0 |
| Synthes (USA) Products, LLC | 3 | 6 |
| Osteomed Corp. | 7 | 0 |
| Walter Lorenz Surgical, Inc. | 6 | 0 |
| Oral Osteodistraction, L.P. | 3 | 0 |
| Howmedica Corp. | 2 | 0 |
| Stryker | 2 | 0 |
| Ace Surgical Supply Co., Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2022 | K220050 | KLS Martin IPS Distraction KLS Martin L.P. | MQN |
| Mar 13, 2019 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products, LLC | MQN |
| Sep 11, 2018 | K181504 | Stryker Pediatric Mandibular Distractor 2 Stryker | MQN |
| May 8, 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC | MQN |
| Dec 1, 2016 | K161470 | Internal Distraction - Sterile KLS Martin L.P. | MQN |
| May 28, 2015 | K143285 | Mandible External Fixator - MR Conditional Synthes USA Products, LLC | MQN |
| Mar 20, 2014 | K133398 | STRYKER PEDIATRIC MANDIBLE DISTRACTOR Stryker | MQN |
| Aug 23, 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM Synthes, Inc. | MQN |
| Dec 17, 2008 | K080458 | MIS CREST WIDENER Mis - Implant Technologies , Ltd., IL | MQN |
| Dec 15, 2008 | K080542 | DISTRAX John W. King | MQN |
| May 14, 2008 | K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM Synthes (Usa) | MQN |
| Dec 20, 2007 | K072764 | KLS MARTIN XTERNAL FIXATOR KLS Martin L.P. | MQN |
| Aug 10, 2007 | K071628 | STRYKER EXTERNAL FIXATION SYSTEM Stryker Cmf | MQN |
| May 11, 2007 | K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE Custom Scientific | MQN |
| Mar 2, 2007 | K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Nov 17, 2006 | K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED Osteomed LP | MQN |
| Aug 31, 2006 | K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT Synthes (Usa) | MQN |
| Jun 2, 2006 | K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM Synthes (Usa) | MQN |
| Aug 22, 2005 | K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM Medartis, Inc. | MQN |
| Apr 12, 2005 | K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR Synthes (Usa) | MQN |
| Mar 15, 2005 | K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR Synthes (Usa) | MQN |
| Feb 10, 2005 | K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Jan 28, 2005 | K042278 | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) Oral Osteodistraction, L.P. | MQN |
| Apr 14, 2004 | K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR Synthes (Usa) | MQN |
| Mar 31, 2004 | K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR Synthes (Usa) | MQN |
| Mar 23, 2004 | K034045 | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 Oral Osteodistraction, L.P. | MQN |
| Feb 27, 2004 | K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM KLS-Martin L.P. | MQN |
| Dec 3, 2003 | K030485 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR Newmedical Technology, Inc. | MQN |
| Nov 3, 2003 | K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM Osteomed LP | MQN |
| Oct 29, 2003 | K033065 | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES Synthes (Usa) | MQN |
| Oct 29, 2003 | K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II KLS-Martin L.P. | MQN |
| Sep 10, 2003 | K030790 | OSTEOMED ALVEOLAR DISTRACTION SYSTEM Osteomed LP | MQN |
| Jun 17, 2003 | K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. | MQN |
| Feb 4, 2003 | K014001 | DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 Oral Osteodistraction, L.P. | MQN |
| Aug 14, 2002 | K013618 | INTRAORAL MANDIBULAR DISTRACTION SYSTEM Osteomed Corp. | MQN |
| Feb 22, 2002 | K020407 | LORENZ BLUE DEVICE Walter Lorenz Surgical, Inc. | MQN |
| Jun 29, 2001 | K010139 | ZURICH DISTRACTION SYSTEM KLS-Martin L.P. | MQN |
| Oct 10, 2000 | K002152 | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION KLS-Martin L.P. | MQN |
| Jul 24, 2000 | K000580 | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 KLS-Martin L.P. | MQN |
| Jun 26, 2000 | K000992 | MACROPOREDX DISTRACTOR SYSTEM Macropore Biosurgery, Inc. | MQN |
| Jan 19, 2000 | K993869 | INTER-OS BONE GENERATOR Inter-Os Technologies, LLC | MQN |
| Nov 19, 1999 | K992952 | LORENZ DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
| Sep 17, 1999 | K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. | MQN |
| Aug 18, 1999 | K991875 | K-L-W INTRAORAL DISTRACTOR KLS-Martin L.P. | MQN |
| Jun 16, 1999 | K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM Osteomed Corp. | MQN |
| Feb 10, 1999 | K984117 | INNOVA TELESCOPIC DISTRACTOR Innova Corp. | MQN |
| Jan 26, 1999 | K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR KLS-Martin L.P. | MQN |
| Nov 30, 1998 | K983515 | KLS INTRAORAL VERTICAL DISTRACTOR KLS-Martin L.P. | MQN |
| Nov 12, 1998 | K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
| Oct 23, 1998 | K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
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