Cleared Traditional

ARTHREX BIO-TRANSFIX

K011172 · Arthrex, Inc. · Orthopedic

Jun 2001

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K011172 is an FDA 510(k) clearance for the ARTHREX BIO-TRANSFIX, a Staple, Absorbable (Class II — Special Controls, product code MNU), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on June 19, 2001, 63 days after receiving the submission on April 17, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K011172 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2001
Decision Date	June 19, 2001
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF