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Activ Fuse

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202307

by Newclip Technics

Identifiers

510(k) Number
K202307 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Activ Fuse is a system of ankle arthrodesis plates and screws designed for bone reconstruction in adults. The device is used for the fixation of fractures and to perform tibiotalar or tibiotalocalcaneal ankle arthrodesis in both primary and revision surgeries.

The system accommodates multiple surgical approaches, including anterior, posterior, and anterolateral, for the distal tibia, talus, and calcaneus. This device has received FDA 510k clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Activ Fuse - Ankle arthrodesis plates - Newclip Technics, Activ Fuse - Ankle arthrodesis plates - Newclip Technics, Foot & Ankle Documentation - Newclip Technics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Newclip Technics

Sources (1)

  • FDA 510(k) K202307 24 fields · synced Sep 22, 2026