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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 K033679
Device Name COPSIOS BONE VOID FILLER (BVF)
Applicant
Centerpulse Spine-Tech, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact TIM MILLER
Correspondent
Centerpulse Spine-Tech, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact TIM MILLER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/24/2003
Decision Date 07/07/2004
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
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