Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K183113.

When was DePuy Synthes Maxillofacial Portfolio - MR Conditional approved by the FDA?

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

What company makes DePuy Synthes Maxillofacial Portfolio - MR Conditional?

DePuy Synthes Maxillofacial Portfolio - MR Conditional is manufactured by Synthes (USA) Products, LLC.

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.

Other Devices by Synthes (USA) Products, LLC

K161590MatrixRIB Fixation System K160167DePuy Synthes TFNA Augmentation System K172157DePuy Synthes Femoral Recon Nail System K170802TRAUMACEM™ V+ Injectable Bone Cement K153587Taps for Resorbable Screws K180213Titanium TomoFix Medial High Tibia Plate Anatomical

View all 23 devices →

Related Devices (Code: MQN)

K161470Internal Distraction - SterileKLS Martin L.P. K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC K181504Stryker Pediatric Mandibular Distractor 2Stryker K220050KLS Martin IPS DistractionKLS 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.

↑