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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K030581
Device Name BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received02/24/2003
Decision Date 06/26/2003
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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