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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 K060350
Device Name CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Applicant Contact WHITNEY G TURNING
Correspondent
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Correspondent Contact WHITNEY G TURNING
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/10/2006
Decision Date 02/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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