Cleared Traditional

MITEK ANCHOR DRILL

K892903 · Mitek Surgical Products, Inc. · Orthopedic
Oct 1989
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K892903 is an FDA 510(k) clearance for the MITEK ANCHOR DRILL, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Mitek Surgical Products, Inc. (Dedham, US). The FDA issued a Cleared decision on October 6, 1989, 169 days after receiving the submission on April 20, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K892903 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1989
Decision Date October 06, 1989
Days to Decision 169 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