BLACKSTONE POSTERIOR CERVICAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

BLACKSTONE MEDICAL, INC.

The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Posterior Cervical System.

Pre-market Notification Details

Device IDK030197
510k NumberK030197
Device Name:BLACKSTONE POSTERIOR CERVICAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
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 CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-21
Decision Date2003-06-12
Summary:summary

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