Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760) → MQN — External Mandibular Fixator And/Or Distractor # MQN · External Mandibular Fixator And/Or Distractor _Dental · 21 CFR 872.4760 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN ## Overview - **Product Code:** MQN - **Device Name:** External Mandibular Fixator And/Or Distractor - **Regulation:** [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K220050.md) | KLS Martin IPS Distraction | KLS Martin L.P. | Aug 11, 2022 | SESE | | [K183113](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K183113.md) | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | Mar 13, 2019 | SESE | | [K181504](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K181504.md) | Stryker Pediatric Mandibular Distractor 2 | Stryker | Sep 11, 2018 | SESE | | [K162594](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K162594.md) | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | May 8, 2017 | SESE | | [K161470](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K161470.md) | Internal Distraction - Sterile | KLS Martin L.P. | Dec 1, 2016 | SESE | | [K143285](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K143285.md) | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | May 28, 2015 | SESE | | [K133398](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K133398.md) | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | Stryker | Mar 20, 2014 | SESE | | [K121502](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K121502.md) | SYNTHES CURVILINEAR DISTRACTION SYSTEM | Synthes, Inc. | Aug 23, 2012 | SESE | | [K080458](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K080458.md) | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. | Dec 17, 2008 | SESE | | [K080542](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K080542.md) | DISTRAX | John W. King | Dec 15, 2008 | SESE | | [K080153](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K080153.md) | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | May 14, 2008 | SESE | | [K072764](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K072764.md) | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | Dec 20, 2007 | SESE | | [K071628](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K071628.md) | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf | Aug 10, 2007 | SESE | | [K062572](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K062572.md) | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific | May 11, 2007 | SESE | | [K063792](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K063792.md) | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | Osteomed LP | Mar 2, 2007 | SESE | | [K062851](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K062851.md) | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | Osteomed LP | Nov 17, 2006 | SESE | | [K062299](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K062299.md) | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) | Aug 31, 2006 | SESE | | [K060138](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K060138.md) | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) | Jun 2, 2006 | SESE | | [K051946](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K051946.md) | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis, Inc. | Aug 22, 2005 | SESE | | [K043555](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN/K043555.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MQN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com