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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K052631
Device Name SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
Applicant
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact DENISE LUCIANO
Correspondent
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact DENISE LUCIANO
Regulation Number888.3030
Classification Product Code
JDR  
Date Received09/26/2005
Decision Date 10/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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