BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

Spinal Vertebral Body Replacement Device

BLACKSTONE MEDICAL, INC.

The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Peek Vertebral Body Replacement System.

Pre-market Notification Details

Device IDK033702
510k NumberK033702
Device Name:BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield,  MA  01104
ContactDean E Ciporkin
CorrespondentDean E Ciporkin
BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield,  MA  01104
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-25
Decision Date2004-03-31
Summary:summary

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