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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 K060271
Device Name SPIRALOK ANCHOR
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact Ruth Forstadt
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact Ruth Forstadt
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received02/01/2006
Decision Date 05/04/2006
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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