MQN · External Mandibular Fixator And/Or Distractor
Dental · 21 CFR 872.4760 · Class 2
Overview
| Product Code | MQN |
|---|---|
| Device Name | External Mandibular Fixator And/Or Distractor |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | Aug 11, 2022 | SESE |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | Mar 13, 2019 | SESE |
| K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | Sep 11, 2018 | SESE |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | May 8, 2017 | SESE |
| K161470 | Internal Distraction - Sterile | KLS Martin L.P. | Dec 1, 2016 | SESE |
| K143285 | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | May 28, 2015 | SESE |
| K133398 | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | Stryker | Mar 20, 2014 | SESE |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | Synthes, Inc. | Aug 23, 2012 | SESE |
| K080458 | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. | Dec 17, 2008 | SESE |
| K080542 | DISTRAX | John W. King | Dec 15, 2008 | SESE |
| K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | May 14, 2008 | SESE |
| K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | Dec 20, 2007 | SESE |
| K071628 | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf | Aug 10, 2007 | SESE |
| K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific | May 11, 2007 | SESE |
| K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | Mar 2, 2007 | SESE |
| K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | Osteomed LP | Nov 17, 2006 | SESE |
| K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) | Aug 31, 2006 | SESE |
| K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) | Jun 2, 2006 | SESE |
| K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis, Inc. | Aug 22, 2005 | SESE |
| K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | Synthes (Usa) | Apr 12, 2005 | SESE |
Top Applicants
- Synthes (Usa) — 12 clearances
- KLS-Martin L.P. — 10 clearances
- Walter Lorenz Surgical, Inc. — 6 clearances
- Osteomed LP — 5 clearances
- KLS Martin L.P. — 3 clearances
