Cleared Traditional

FEMORAL CEMENT REMOVAL INSTRUMENTS

K870217 · Kenneth J. Hoek, M.D., Inc. · Orthopedic

Feb 1987

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K870217 is an FDA 510(k) clearance for the FEMORAL CEMENT REMOVAL INSTRUMENTS, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Kenneth J. Hoek, M.D., Inc. (Ukiah, US). The FDA issued a Cleared decision on February 6, 1987, 16 days after receiving the submission on January 21, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K870217 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 1987
Decision Date	February 06, 1987
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—