Cleared Traditional

K220947 - Arthrex Knotless AC Repair Devices (FDA 510(k) Clearance)

K220947 · Arthrex, Inc. · Orthopedic device

Jun 2022

Decision

66d

Days

Class 2

Risk

K220947 is an FDA 510(k) clearance for the Arthrex Knotless AC Repair Devices. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on June 6, 2022, 66 days after receiving the submission on April 1, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K220947 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2022
Decision Date	June 06, 2022
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF