EXCELLA II SPINAL SYSTEM MODEL EC2-00

Thoracolumbosacral Pedicle Screw System

INNOVASIS, INC.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella Ii Spinal System Model Ec2-00.

Pre-market Notification Details

Device IDK102248
510k NumberK102248
Device Name:EXCELLA II SPINAL SYSTEM MODEL EC2-00
ClassificationThoracolumbosacral Pedicle Screw System
Applicant INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City,  UT  84107
ContactMarshall C Mccarty
CorrespondentMarshall C Mccarty
INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City,  UT  84107
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-09
Decision Date2010-10-07
Summary:summary

NIH GUDID Devices

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