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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K040500
Device Name ARTHROTEK LACTONAIL
Applicant
Arthrotek, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact TRACY J BICKEL
Correspondent
Arthrotek, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact TRACY J BICKEL
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/26/2004
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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