DIAMONDBACK SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

EMINENT SPINE

The following data is part of a premarket notification filed by Eminent Spine with the FDA for Diamondback Spinal System.

Pre-market Notification Details

Device IDK100377
510k NumberK100377
Device Name:DIAMONDBACK SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant EMINENT SPINE 8202 SHERMAN ROAD Chesterland,  OH  44026 -2141
ContactKaren Warden
CorrespondentKaren Warden
EMINENT SPINE 8202 SHERMAN ROAD Chesterland,  OH  44026 -2141
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-12
Decision Date2010-04-22
Summary:summary

NIH GUDID Devices

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