Cleared Traditional

K013888 - FIXATION (STEINMANN) PINS
(FDA 510(k) Clearance)

K013888 · Miltex, Inc. · Orthopedic

May 2002

Decision

159d

Days

Class 2

Risk

K013888 is an FDA 510(k) clearance for the FIXATION (STEINMANN) PINS. This device is classified as a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY).

Submitted by Miltex, Inc. (Bethpage, US). The FDA issued a Cleared decision on May 1, 2002, 159 days after receiving the submission on November 23, 2001.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K013888 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2001
Decision Date	May 01, 2002
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF