Cleared Traditional

K052776 - TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD (FDA 510(k) Clearance)

K052776 · Arthrex, Inc. · Orthopedic device

Dec 2005

Decision

71d

Days

Class 2

Risk

K052776 is an FDA 510(k) clearance for the TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD. 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 December 13, 2005, 71 days after receiving the submission on October 3, 2005.

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

Submission Details

510(k) Number	K052776 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 03, 2005
Decision Date	December 13, 2005
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF