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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 K041069
Device Name SPIRALOK ANCHOR
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Applicant Contact KAREN SYLVIA
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD,  MA  02062
Correspondent Contact KAREN SYLVIA
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received04/26/2004
Decision Date 11/09/2004
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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