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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 a medical device manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under approval 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. It is manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K191826.

When was KeYi Total Hip System approved by the FDA?

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

What company makes KeYi Total Hip System?

KeYi Total Hip System is manufactured by Beijing Keyi Medical Device Technology Co., Ltd..

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

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

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Beijing Keyi Medical Device Technology Co., Ltd.

K162380Locking Plate System K190567KeYi Spinal Fixation System K230120KeYi Total Knee System

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

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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