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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
Recalls CDRH Recalls
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