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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K042100
Device Name BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
Applicant
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Applicant Contact DEAN CIPORKIN
Correspondent
BLACKSTONE MEDICAL, INC.
90 BROOKSDALE DR.
SPRINGFIELD,  MA  01104
Correspondent Contact DEAN CIPORKIN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received08/04/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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