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FDA 510(k)

Xpert Knee

K-Number: K250155 · 2025-04-23

ApplicantNewclip Technics
Decision Date2025-04-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xpert Knee is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K250155. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Knee?

Xpert Knee is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Newclip Technics. The 510(k) number is K250155.

When did Xpert Knee receive FDA 510(k) clearance?

Xpert Knee received FDA 510(k) clearance on 2025-04-23, under 510(k) number K250155.

Who is the listed applicant for Xpert Knee?

The FDA 510(k) record lists Newclip Technics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xpert Knee?

The FDA product code for Xpert Knee is HRS.

Other records listing Newclip Technics 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.

K261511Xpert AnkleK261191Alians Elbow SK261038Xpert PFPK253906Xpert HandK250767Newclip Patient-matched instrumentation non sterile PSIK243912Newclip Patient-matched instrumentation non sterile PSI

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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