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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K081684
Device Name BLACKSTONE PEDICLE SCREW SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Applicant Contact WHITNEY G TORNING
Correspondent
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Correspondent Contact WHITNEY G TORNING
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/17/2008
Decision Date 09/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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