FDA Product Code
FDA Product Code MQN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4760
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022-08-11 | Traditional | PDF ↗ |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-03-13 | Traditional | PDF ↗ |
| K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018-09-11 | Traditional | PDF ↗ |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-05-08 | Traditional | PDF ↗ |
| K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016-12-01 | Traditional | PDF ↗ |
| K143285 | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | 2015-05-28 | Traditional | PDF ↗ |
| K133398 | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | Stryker | 2014-03-20 | Traditional | PDF ↗ |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | Synthes, Inc. | 2012-08-23 | Traditional | PDF ↗ |
| K080458 | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. | 2008-12-17 | Traditional | PDF ↗ |
| K080542 | DISTRAX | John W. King | 2008-12-15 | Traditional | PDF ↗ |
| K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | 2008-05-14 | Traditional | PDF ↗ |
| K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | 2007-12-20 | Traditional | PDF ↗ |
| K071628 | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf | 2007-08-10 | Traditional | PDF ↗ |
| K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific | 2007-05-11 | Traditional | PDF ↗ |
| K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | 2007-03-02 | Traditional | PDF ↗ |
| K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | Osteomed LP | 2006-11-17 | Traditional | PDF ↗ |
| K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) | 2006-08-31 | Special | PDF ↗ |
| K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) | 2006-06-02 | Traditional | PDF ↗ |
| K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | Synthes (Usa) | 2005-04-12 | Traditional | PDF ↗ |
| K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | 2005-03-15 | Traditional | PDF ↗ |
| K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | 2005-02-10 | Traditional | PDF ↗ |
| K042278 | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) | Oral Osteodistraction, L.P. | 2005-01-28 | Traditional | PDF ↗ |
| K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | 2004-04-14 | Traditional | PDF ↗ |
| K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | Synthes (Usa) | 2004-03-31 | Traditional | PDF ↗ |
| K034045 | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 | Oral Osteodistraction, L.P. | 2004-03-23 | Traditional | PDF ↗ |
| K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | KLS-Martin L.P. | 2004-02-27 | Traditional | PDF ↗ |
| K030485 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | Newmedical Technology, Inc. | 2003-12-03 | Traditional | PDF ↗ |
| K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM | Osteomed LP | 2003-11-03 | Traditional | PDF ↗ |
| K033065 | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES | Synthes (Usa) | 2003-10-29 | Traditional | PDF ↗ |
| K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | KLS-Martin L.P. | 2003-10-29 | Traditional | PDF ↗ |
| K030790 | OSTEOMED ALVEOLAR DISTRACTION SYSTEM | Osteomed LP | 2003-09-10 | Traditional | PDF ↗ |
| K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. | 2003-06-17 | Special | PDF ↗ |
| K014001 | DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 | Oral Osteodistraction, L.P. | 2003-02-04 | Traditional | PDF ↗ |
| K013618 | INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Osteomed Corp. | 2002-08-14 | Traditional | PDF ↗ |
| K020407 | LORENZ BLUE DEVICE | Walter Lorenz Surgical, Inc. | 2002-02-22 | Special | PDF ↗ |
| K010139 | ZURICH DISTRACTION SYSTEM | KLS-Martin L.P. | 2001-06-29 | Traditional | PDF ↗ |
| K002152 | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION | KLS-Martin L.P. | 2000-10-10 | Traditional | PDF ↗ |
| K000580 | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 | KLS-Martin L.P. | 2000-07-24 | Traditional | PDF ↗ |
| K000992 | MACROPOREDX DISTRACTOR SYSTEM | Macropore Biosurgery, Inc. | 2000-06-26 | Traditional | PDF ↗ |
| K993869 | INTER-OS BONE GENERATOR | Inter-Os Technologies, LLC | 2000-01-19 | Traditional | PDF ↗ |
| K992952 | LORENZ DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1999-11-19 | Traditional | PDF ↗ |
| K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. | 1999-09-17 | Special | PDF ↗ |
| K991875 | K-L-W INTRAORAL DISTRACTOR | KLS-Martin L.P. | 1999-08-18 | Traditional | PDF ↗ |
| K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM | Osteomed Corp. | 1999-06-16 | Traditional | PDF ↗ |
| K984117 | INNOVA TELESCOPIC DISTRACTOR | Innova Corp. | 1999-02-10 | Traditional | PDF ↗ |
| K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | KLS-Martin L.P. | 1999-01-26 | Traditional | PDF ↗ |
| K983515 | KLS INTRAORAL VERTICAL DISTRACTOR | KLS-Martin L.P. | 1998-11-30 | Traditional | PDF ↗ |
| K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1998-11-12 | Traditional | PDF ↗ |
| K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1998-10-23 | Traditional | PDF ↗ |
| K981275 | SYNTHES (USA) RATCHETING DISTRACTOR | Synthes (Usa) | 1998-06-25 | Traditional | PDF ↗ |
| K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET | Synthes (Usa) | 1998-06-22 | Traditional | PDF ↗ |
| K973275 | KLS-MARTIN INTRAORAL DISTRACTOR | KLS-Martin L.P. | 1997-11-20 | Traditional | PDF ↗ |
| K973018 | SYNTHES MINI LENGTHENING APPARATUS | Synthes (Usa) | 1997-11-10 | Traditional | PDF ↗ |
| K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | KLS-Martin L.P. | 1997-06-24 | Traditional | PDF ↗ |
| K962272 | SYNTHES MANDIBLE DISTRACTOR | Synthes (Usa) | 1996-08-30 | Traditional | PDF ↗ |
| K960297 | MANDIBULAR BONE DISTRACTOR II | Howmedica Corp. | 1996-08-06 | Traditional | PDF ↗ |
| K955640 | LORENZ MANDIBULAR DISTRACTOR | Biomet, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | Ace Surgical Supply Co., Inc. | 1996-02-06 | Traditional | PDF ↗ |
| K945674 | MANDIBULAR BONE DISTRACTOR | Howmedica Corp. | 1995-06-02 | Traditional | PDF ↗ |
Product code MQN · Class II · Dental. Data: openFDA.