SUSTAIN SPACER

Spinal Vertebral Body Replacement Device

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sustain Spacer.

Pre-market Notification Details

Device IDK031302
510k NumberK031302
Device Name:SUSTAIN SPACER
ClassificationSpinal Vertebral Body Replacement Device
Applicant GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville,  PA  19460
ContactDaniel S Paul
CorrespondentDaniel S Paul
GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville,  PA  19460
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-24
Decision Date2003-06-27
Summary:summary

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