Product code MQN
- Device name
- External Mandibular Fixator And/Or Distractor
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4760
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022-08-11 |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-03-13 |
| K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018-09-11 |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-05-08 |
| K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016-12-01 |
| K143285 | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | 2015-05-28 |
| K133398 | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | Stryker | 2014-03-20 |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | Synthes, Inc. | 2012-08-23 |
| K080458 | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. | 2008-12-17 |
| K080542 | DISTRAX | John W. King | 2008-12-15 |
| K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | 2008-05-14 |
| K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | 2007-12-20 |
| K071628 | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf | 2007-08-10 |
| K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific | 2007-05-11 |
| K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | 2007-03-02 |
| K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | Osteomed LP | 2006-11-17 |
| K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) | 2006-08-31 |
| K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) | 2006-06-02 |
| K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis, Inc. | 2005-08-22 |
| K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | Synthes (Usa) | 2005-04-12 |
| K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | 2005-03-15 |
| K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | 2005-02-10 |
| K042278 | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) | Oral Osteodistraction, L.P. | 2005-01-28 |
| K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) | 2004-04-14 |
| K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | Synthes (Usa) | 2004-03-31 |
| K034045 | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 | Oral Osteodistraction, L.P. | 2004-03-23 |
| K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | KLS-Martin L.P. | 2004-02-27 |
| K030485 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | Newmedical Technology, Inc. | 2003-12-03 |
| K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM | Osteomed LP | 2003-11-03 |
| K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | KLS-Martin L.P. | 2003-10-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888118154986 | LEVEL ONE CMF | KLS-Martin L.P. | 2026-10-21 |
| 10888118154979 | LEVEL ONE CMF | KLS-Martin L.P. | 2026-10-21 |
| 00888118154965 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | 2026-10-21 |
| 00888118154934 | LEVEL ONE CMF | KLS-Martin L.P. | 2026-10-21 |
| 00888118154927 | LEVEL ONE CMF | KLS-Martin L.P. | 2026-10-21 |
| 00888118154910 | LEVEL ONE CMF | KLS-Martin L.P. | 2026-10-21 |
| 00888118128638 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118128645 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118128652 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118128669 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118128676 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118128683 | LEVEL ONE CMF | KLS-Martin L.P. | 2020-08-24 |
| 00888118107800 | LEVEL ONE CMF | KLS-Martin L.P. | 2017-03-31 |
| 00888118107817 | LEVEL ONE CMF | KLS-Martin L.P. | 2017-03-31 |
| 00888118105554 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | 2016-12-16 |
| 00888118105431 | DISTRACTION, INTERNAL, STERILE | KLS-Martin L.P. | 2016-12-16 |
| 00888118097880 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118097873 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118097866 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118097842 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118097767 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118097750 | LEVEL ONE CMF | KLS-Martin L.P. | 2016-04-08 |
| 00888118082718 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118082732 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118082787 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118082800 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118082817 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118082824 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118083944 | DISTRACTION, INTERNAL | KLS-Martin L.P. | 2016-03-24 |
| 00888118083074 | DISTRACTION, EXTERNAL | KLS-Martin L.P. | 2016-03-23 |