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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 K060693
Device Name MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
Applicant
Arthrotek, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact LESTER F PADILLA
Correspondent
Arthrotek, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact LESTER F PADILLA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/15/2006
Decision Date 06/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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