Mandible External Fixator - MR Conditional
FDA 510(k) K143285 · Synthes USA Products, LLC
510(k) numberK143285
Submission
- Device name
- Mandible External Fixator - MR Conditional
- Applicant
- Synthes USA Products, LLC
West Chester, PA, US - Received
- November 17, 2014
- Decision date
- May 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220050 | KLS Martin IPS DistractionMQN · Traditional | KLS Martin L.P. | 08/11/2022SE |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN · Traditional | Synthes (USA) Products, LLC | 03/13/2019SE |
| K181504 | Stryker Pediatric Mandibular Distractor 2MQN · Traditional | Stryker | 09/11/2018SE |
| K162594 | Craniomaxillofacial Distraction System (CMFD)MQN · Traditional | Synthes USA Products, LLC | 05/08/2017SE |
| K161470 | Internal Distraction - SterileMQN · Traditional | KLS Martin L.P. | 12/01/2016SE |
| K133398 | Stryker Pediatric Mandible DistractorMQN · Traditional | Stryker | 03/20/2014SE |
| K121502 | Synthes Curvilinear Distraction SystemMQN · Traditional | Synthes, Inc. | 08/23/2012SE |
| K080458 | Mis Crest WidenerMQN · Traditional | Mis - Implant Technologies , Ltd. | 12/17/2008SE |
| K080542 | DistraxMQN · Traditional | John W. King | 12/15/2008SE |
| K080153 | Synthes (USA) Curvilinear Distraction SystemMQN · Traditional | Synthes (Usa) | 05/14/2008SE |
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| K210408 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 04/08/2021SE |
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| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…HSB · Traditional | 09/23/2020SE |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN · Traditional | 09/18/2020SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | 09/10/2020SE |
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| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
Questions and answers
When was Mandible External Fixator - MR Conditional cleared by the FDA?
Mandible External Fixator - MR Conditional (K143285) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 192 days after the submission was received.
What is the product code of K143285?
The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.