BLACKSTONE SURGICAL TITANIUM MESH

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 Surgical Titanium Mesh.

Pre-market Notification Details

Device IDK030744
510k NumberK030744
Device Name:BLACKSTONE SURGICAL TITANIUM MESH
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 Received2003-03-10
Decision Date2003-06-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.