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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K011048
Device Name BSM BONE SUBSTITUTE MATERIAL
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact LYNNETTE WHITAKER
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/06/2001
Decision Date 11/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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