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FDA 510(k)

XN Knee Prosthesis System

K-Number: K232175 · 2024-04-14

ApplicantBeijing Chunlizhengda Medical Instruments Co., Ltd.
Decision Date2024-04-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XN Knee Prosthesis System is a medical device manufactured by Beijing Chunlizhengda Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-04-14 under approval number K232175. 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 XN Knee Prosthesis System?

XN Knee Prosthesis System is a medical device that received FDA 510(k) clearance on 2024-04-14. It is manufactured by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The 510(k) number is K232175.

When was XN Knee Prosthesis System approved by the FDA?

XN Knee Prosthesis System received FDA 510(k) clearance on 2024-04-14, under approval number K232175.

What company makes XN Knee Prosthesis System?

XN Knee Prosthesis System is manufactured by Beijing Chunlizhengda Medical Instruments Co., Ltd..

What is the FDA product code for XN Knee Prosthesis System?

The FDA product code for XN Knee Prosthesis System is JWH.

Related Clinical Trials

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING NCT05124652 An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation RECRUITING NCT05498662 An Observational Study of the T3 Pro Dental Implant System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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