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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 the device name listed in this FDA 510(k) record. The listed applicant is Beijing Chunlizhengda Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-04-14 under 510(k) 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. The listed applicant is Beijing Chunlizhengda Medical Instruments Co., Ltd.. The 510(k) number is K232175.

When did XN Knee Prosthesis System receive FDA 510(k) clearance?

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

Who is the listed applicant for XN Knee Prosthesis System?

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

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

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

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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