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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 K041939
Device Name BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
Applicant
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Applicant Contact DEAN E CIPORKIN
Correspondent
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Correspondent Contact DEAN E CIPORKIN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/19/2004
Decision Date 08/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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