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FDA 510(k)

Depuy Synthes Maxillofacial Portfolio - MR Conditional

K-Number: K192655 · 2019-12-30

ApplicantSynthes (USA) Products, LLC
Decision Date2019-12-30
Product CodeJEY
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 2019-12-30 under approval number K192655. The device is classified under product code JEY. 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 2019-12-30. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K192655.

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

Depuy Synthes Maxillofacial Portfolio - MR Conditional received FDA 510(k) clearance on 2019-12-30, under approval number K192655.

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 JEY.

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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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