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FDA 510(k)

MP LeFort I Plates

K-Number: K171364 · 2017-07-24

ApplicantStryker
Decision Date2017-07-24
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MP LeFort I Plates is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K171364. 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 MP LeFort I Plates?

MP LeFort I Plates is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Stryker. The 510(k) number is K171364.

When did MP LeFort I Plates receive FDA 510(k) clearance?

MP LeFort I Plates received FDA 510(k) clearance on 2017-07-24, under 510(k) number K171364.

Who is the listed applicant for MP LeFort I Plates?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MP LeFort I Plates?

The FDA product code for MP LeFort I Plates is JEY.

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Related Devices (Code: 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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