FDA 510(k)

Activ Ankle

K-Number: K173641 · 2018-01-16

Decision Date2018-01-16

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Activ Ankle is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K173641. 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 Activ Ankle?

Activ Ankle is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is Newclip Technics. The 510(k) number is K173641.

When did Activ Ankle receive FDA 510(k) clearance?

Activ Ankle received FDA 510(k) clearance on 2018-01-16, under 510(k) number K173641.

Who is the listed applicant for Activ Ankle?

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 Activ Ankle?

The FDA product code for Activ Ankle 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.