Cleared Traditional

K061925 - MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS (FDA 510(k) Clearance)

K061925 · Arthrex, Inc. · Orthopedic device

Oct 2006

Decision

116d

Days

Class 2

Risk

K061925 is an FDA 510(k) clearance for the MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS. 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 October 31, 2006, 116 days after receiving the submission on July 7, 2006.

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

Submission Details

510(k) Number	K061925 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 07, 2006
Decision Date	October 31, 2006
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF