BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR

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 Ascent Poct System Parallel Rod Connector.

Pre-market Notification Details

Device IDK073654
510k NumberK073654
Device Name:BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne,  NJ  07470
ContactWhitney G Torning
CorrespondentWhitney G Torning
BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne,  NJ  07470
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-01-24
Summary:summary

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