FDA 510(k)

KeYi Total Hip System

K-Number: K191826 · 2020-05-14

ApplicantBeijing Keyi Medical Device Technology Co., Ltd.

Decision Date2020-05-14

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KeYi Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K191826. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeYi Total Hip System?

KeYi Total Hip System is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K191826.

When did KeYi Total Hip System receive FDA 510(k) clearance?

KeYi Total Hip System received FDA 510(k) clearance on 2020-05-14, under 510(k) number K191826.

Who is the listed applicant for KeYi Total Hip System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeYi Total Hip System?

The FDA product code for KeYi Total Hip System is LPH.

Other records listing Beijing Keyi Medical Device Technology Co., Ltd. as applicant

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.

K230120KeYi Total Knee System K190567KeYi Spinal Fixation System K162380Locking Plate System

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Official Source

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