Cleared Traditional

GLENOID DRILL

K863147 · Bowen & Company, Inc. · Orthopedic
Sep 1986
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K863147 is an FDA 510(k) clearance for the GLENOID DRILL, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on September 5, 1986, 21 days after receiving the submission on August 15, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K863147 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1986
Decision Date September 05, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HTW — Bit, Drill
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540