MODIFICATION TO BLACKSTONE SPINAL FIXATION 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 Modification To Blackstone Spinal Fixation System.

Pre-market Notification Details

Device IDK023498
510k NumberK023498
Device Name:MODIFICATION TO BLACKSTONE SPINAL FIXATION 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  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-18
Decision Date2002-11-13
Summary:summary

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