Cleared Special

K023134 - JET-X TIN COATED HALF PINS (FDA 510(k) Clearance)

K023134 · Smith & Nephew, Inc. · Orthopedic device

Oct 2002

Decision

19d

Days

Class 2

Risk

K023134 is an FDA 510(k) clearance for the JET-X TIN COATED HALF PINS. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 9, 2002, 19 days after receiving the submission on September 20, 2002.

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

Submission Details

510(k) Number	K023134 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 2002
Decision Date	October 09, 2002
Days to Decision	19 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF