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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device
510(k) Number K051246
Device Name CONSTRUX MINI PEEK VBR SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Applicant Contact DEAN E CIPORKIN
Correspondent
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Correspondent Contact DEAN E CIPORKIN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/16/2005
Decision Date 06/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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