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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K041274
Device Name RESORBABLE INTERFERENCE SCREW
Applicant
Arthrotek, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact GARY BAKER
Correspondent
Arthrotek, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact GARY BAKER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/12/2004
Decision Date 07/28/2004
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
Recalls CDRH Recalls
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