Cleared Traditional

K023119 - BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B (FDA 510(k) Clearance)

K023119 · Arthrex, Inc. · Orthopedic device

Dec 2002

Decision

90d

Days

Class 2

Risk

K023119 is an FDA 510(k) clearance for the BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B. 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 18, 2002, 90 days after receiving the submission on September 19, 2002.

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

Submission Details

510(k) Number	K023119 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 19, 2002
Decision Date	December 18, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF