Cleared Traditional

TORQUEDRIVER WRENCH

K870053 · Jerome Medical · Orthopedic
Mar 1987
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K870053 is an FDA 510(k) clearance for the TORQUEDRIVER WRENCH, a Wrench (Class I — General Controls, product code HXC), submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on March 11, 1987, 63 days after receiving the submission on January 7, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K870053 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1987
Decision Date March 11, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HXC — Wrench
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540