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FDA 510(k)

MPO Total Knee Systems MR Labeling

K-Number: K152631 · 2016-03-23

ApplicantMicroport Orthopedics, Inc.
Decision Date2016-03-23
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MPO Total Knee Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152631. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPO Total Knee Systems MR Labeling?

MPO Total Knee Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K152631.

When did MPO Total Knee Systems MR Labeling receive FDA 510(k) clearance?

MPO Total Knee Systems MR Labeling received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152631.

Who is the listed applicant for MPO Total Knee Systems MR Labeling?

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

What is the FDA product code for MPO Total Knee Systems MR Labeling?

The FDA product code for MPO Total Knee Systems MR Labeling is HRY.

Other records listing Microport Orthopedics, Inc. as applicant

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLC

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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