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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K051296
Device Name SIJF CANNULATED SCREW SYSTEM
Applicant
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02780
Applicant Contact SHARON STAROWICZ
Correspondent
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02780
Correspondent Contact SHARON STAROWICZ
Regulation Number888.3040
Classification Product Code
OUR  
Date Received05/18/2005
Decision Date 08/26/2005
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
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