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FDA 510(k)

KeYi Total Knee System

K-Number: K230120 · 2024-04-19

ApplicantBeijing Keyi Medical Device Technology Co., Ltd.
Decision Date2024-04-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeYi Total Knee 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 2024-04-19 under 510(k) number K230120. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeYi Total Knee System?

KeYi Total Knee System is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K230120.

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

KeYi Total Knee System received FDA 510(k) clearance on 2024-04-19, under 510(k) number K230120.

Who is the listed applicant for KeYi Total Knee 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 Knee System?

The FDA product code for KeYi Total Knee System is JWH.

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.

K191826KeYi Total Hip SystemK190567KeYi Spinal Fixation SystemK162380Locking Plate System

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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.

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