FDA 510(k)

Xpert Wrist

K-Number: K213214 · 2021-11-24

Decision Date2021-11-24

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Xpert Wrist is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K213214. 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 Wrist?

Xpert Wrist is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Newclip Technics. The 510(k) number is K213214.

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

Xpert Wrist received FDA 510(k) clearance on 2021-11-24, under 510(k) number K213214.

Who is the listed applicant for Xpert Wrist?

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 Wrist?

The FDA product code for Xpert Wrist 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 Ankle K261191Alians Elbow S K261038Xpert PFP K253906Xpert Hand K250767Newclip Patient-matched instrumentation non sterile PSI K250155Xpert Knee

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Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock 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 Technics K261054RibPlate 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.