Cleared Traditional

K-WIRES AND STEINMANN PINS

K941434 · Omega Surgical Instruments, Inc. · Orthopedic

Oct 1994

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K941434 is an FDA 510(k) clearance for the K-WIRES AND STEINMANN PINS, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Omega Surgical Instruments, Inc. (Grand Blanc, US). The FDA issued a Cleared decision on October 3, 1994, 193 days after receiving the submission on March 24, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K941434 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1994
Decision Date	October 03, 1994
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement