Cleared Traditional

Avenger Radial Head System

K192754 · In2bones USA, LLC · Orthopedic
Jan 2020
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K192754 is an FDA 510(k) clearance for the Avenger Radial Head System, a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II — Special Controls, product code KWI), submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on January 7, 2020, 99 days after receiving the submission on September 30, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3170.

Submission Details

510(k) Number K192754 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2019
Decision Date January 07, 2020
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3170

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