ATLAS SPINE VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

ATLAS SPINE INC.

The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Atlas Spine Vertebral Body Replacement.

Pre-market Notification Details

Device IDK063464
510k NumberK063464
Device Name:ATLAS SPINE VERTEBRAL BODY REPLACEMENT
ClassificationSpinal Vertebral Body Replacement Device
Applicant ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter,  FL  33458
ContactJeannette G Dailey
CorrespondentJeannette G Dailey
ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter,  FL  33458
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-16
Decision Date2007-03-09
Summary:summary

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