Cleared Traditional

K030336 - KMEDIC EXTERNAL FIXATION DEVICES (FDA 510(k) Clearance)

K030336 · Teleflex Medical Group · Orthopedic device

Mar 2003

Decision

34d

Days

Class 2

Risk

K030336 is an FDA 510(k) clearance for the KMEDIC EXTERNAL FIXATION DEVICES. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Teleflex Medical Group (Jaffrey, US). The FDA issued a Cleared decision on March 6, 2003, 34 days after receiving the submission on January 31, 2003.

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

Submission Details

510(k) Number	K030336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 2003
Decision Date	March 06, 2003
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF