Cleared Traditional

K885100 - MCCONNELL REAMER GUIDE
(FDA 510(k) Clearance)

K885100 · Mcconnell Orthopedic · Orthopedic

Jan 1989

Decision

32d

Days

Class 1

Risk

K885100 is an FDA 510(k) clearance for the MCCONNELL REAMER GUIDE, a Reamer (Class I — General Controls, product code HTO), submitted by Mcconnell Orthopedic (Dallas, US). The FDA issued a Cleared decision on January 13, 1989, 32 days after receiving the submission on December 12, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K885100 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 1988
Decision Date	January 13, 1989
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—