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FDA 510(k)

DePuy Synthes Maxillofacial Portfolio - MR Conditional

K-Number: K183113 · 2019-03-13

ApplicantSynthes (USA) Products, LLC
Decision Date2019-03-13
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Maxillofacial Portfolio - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K183113. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Maxillofacial Portfolio - MR Conditional?

DePuy Synthes Maxillofacial Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K183113.

When did DePuy Synthes Maxillofacial Portfolio - MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Maxillofacial Portfolio - MR Conditional received FDA 510(k) clearance on 2019-03-13, under 510(k) number K183113.

Who is the listed applicant for DePuy Synthes Maxillofacial Portfolio - MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Maxillofacial Portfolio - MR Conditional?

The FDA product code for DePuy Synthes Maxillofacial Portfolio - MR Conditional is MQN.

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Related Devices (Code: MQN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220050KLS Martin IPS DistractionKLS Martin L.P.K181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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