Cleared Traditional

K043145 - BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B (FDA 510(k) Clearance)

K043145 · Arthrex, Inc. · Orthopedic device

Feb 2005

Decision

95d

Days

Class 2

Risk

K043145 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 February 18, 2005, 95 days after receiving the submission on November 15, 2004.

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

Submission Details

510(k) Number	K043145 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 2004
Decision Date	February 18, 2005
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF