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

Device IdentifiersubmissionNumberSupplement
M711SR551000 K102248 000
M711UCL39450 K102248 000
M711UCL45570 K102248 000
M711UCL57810 K102248 000
M711E3N475250 K102248 000
M711E3N475300 K102248 000
M711E3N475350 K102248 000
M711E3N475400 K102248 000
M711E3N475450 K102248 000
M711E3N55250 K102248 000
M711E3N55300 K102248 000
M711E3N55350 K102248 000
M711E3N55400 K102248 000
M711E3N55450 K102248 000
M711E3N55500 K102248 000
M711E3N55550 K102248 000
M711E3N65250 K102248 000
M711E3N65300 K102248 000
M711UCL35350 K102248 000
M711UCL30300 K102248 000
M711SR55950 K102248 000
M711SR551050 K102248 000
M711SR551100 K102248 000
M711SR551150 K102248 000
M711SR551200 K102248 000
M711SR55350 K102248 000
M711SR55400 K102248 000
M711SR55450 K102248 000
M711SR554600 K102248 000
M711SR55500 K102248 000
M711SR55550 K102248 000
M711SR55600 K102248 000
M711SR55650 K102248 000
M711SR55700 K102248 000
M711SR55750 K102248 000
M711SR55800 K102248 000
M711SR55850 K102248 000
M711SR55900 K102248 000
M711E3N65350 K102248 000
M711E3N65400 K102248 000
M711ECC45350 K102248 000
M711ECC45400 K102248 000
M711ECC45450 K102248 000
M711ECC55250 K102248 000
M711ECC55300 K102248 000
M711ECC55350 K102248 000
M711ECC55400 K102248 000
M711ECC55450 K102248 000
M711ECC55500 K102248 000
M711ECC55550 K102248 000
M711ECC65250 K102248 000
M711ECC65300 K102248 000
M711ECC65350 K102248 000
M711ECC65400 K102248 000
M711ECC65450 K102248 000
M711ECC65500 K102248 000
M711ECC65550 K102248 000
M711ECC45300 K102248 000
M711ECC45250 K102248 000
M711E3N85600 K102248 000
M711E3N65450 K102248 000
M711E3N65500 K102248 000
M711E3N65550 K102248 000
M711E3N65600 K102248 000
M711E3N75300 K102248 000
M711E3N75350 K102248 000
M711E3N75400 K102248 000
M711E3N75450 K102248 000
M711E3N75500 K102248 000
M711E3N75550 K102248 000
M711E3N75600 K102248 000
M711E3N85300 K102248 000
M711E3N85350 K102248 000
M711E3N85400 K102248 000
M711E3N85450 K102248 000
M711E3N85500 K102248 000
M711E3N85550 K102248 000
M711ECC65600 K102248 000
M711PR55950 K102248 000
M711EM55250 K102248 000
M711MPRL551450 K102248 000
M711MPRL551550 K102248 000
M711MPRL551650 K102248 000
M711MPRL551750 K102248 000
M711MPRL551850 K102248 000
M711MPRL551950 K102248 000
M711MPRL552050 K102248 000
M711MPRL55350 K102248 000
M711MPRL55400 K102248 000
M711MPRL55450 K102248 000
M711MPRL55500 K102248 000
M711MPRL55550 K102248 000
M711MPRL55600 K102248 000
M711MPRL55650 K102248 000
M711MPRL55700 K102248 000
M711MPRL55750 K102248 000
M711MPRL55800 K102248 000
M711MPRL551350 K102248 000
M711MPRL551250 K102248 000
M711MPRL551150 K102248 000
M711MPR551050 K102248 000
M711MPR551150 K102248 000
M711MPR551250 K102248 000
M711MPR551350 K102248 000
M711MPR55350 K102248 000
M711MPR55400 K102248 000
M711MPR55450 K102248 000
M711MPR55500 K102248 000
M711MPR55550 K102248 000
M711MPR55600 K102248 000
M711MPR55650 K102248 000
M711MPR55700 K102248 000
M711MPR55750 K102248 000
M711MPR55800 K102248 000
M711MPR55850 K102248 000
M711MPR55950 K102248 000
M711MPRL551050 K102248 000
M711MPRL55850 K102248 000
M711MPRL55950 K102248 000
M711PR551000 K102248 000
M711PR551050 K102248 000
M711PR551100 K102248 000
M711PR551150 K102248 000
M711PR551200 K102248 000
M711PR551250 K102248 000
M711PR55350 K102248 000
M711PR55400 K102248 000
M711PR55450 K102248 000
M711PR55500 K102248 000
M711PR55550 K102248 000
M711PR55600 K102248 000
M711PR55650 K102248 000
M711PR55700 K102248 000
M711PR55750 K102248 000
M711PR55800 K102248 000
M711PR55850 K102248 000
M711MSR55900 K102248 000
M711MSR55800 K102248 000
M711MSR55700 K102248 000
M711MSR551000 K102248 000
M711MSR551100 K102248 000
M711MSR551200 K102248 000
M711MSR551300 K102248 000
M711MSR551400 K102248 000
M711MSR551500 K102248 000
M711MSR551600 K102248 000
M711MSR551700 K102248 000
M711MSR551800 K102248 000
M711MSR551900 K102248 000
M711MSR552000 K102248 000
M711MSR55350 K102248 000
M711MSR55400 K102248 000
M711MSR55450 K102248 000
M711MSR55500 K102248 000
M711MSR55550 K102248 000
M711MSR55600 K102248 000
M711PR55900 K102248 000
M711ECC75300 K102248 000
M711E2S55300 K102248 000
M711E2S85350 K102248 000
M711E2S85400 K102248 000
M711E2S85450 K102248 000
M711E2S85500 K102248 000
M711E2S85550 K102248 000
M711E2S85600 K102248 000
M711E3475250 K102248 000
M711E3475300 K102248 000
M711E3475350 K102248 000
M711E3475400 K102248 000
M711E3475450 K102248 000
M711E355250 K102248 000
M711E355300 K102248 000
M711E355350 K102248 000
M711E355400 K102248 000
M711E355450 K102248 000
M711E355500 K102248 000
M711E2S85300 K102248 000
M711E2S75600 K102248 000
M711E2S75550 K102248 000
M711E2S55350 K102248 000
M711E2S55400 K102248 000
M711E2S55450 K102248 000
M711E2S55500 K102248 000
M711E2S55550 K102248 000
M711E2S65250 K102248 000
M711E2S65350 K102248 000
M711E2S65400 K102248 000
M711E2S65450 K102248 000
M711E2S65500 K102248 000
M711E2S65550 K102248 000
M711E2S65600 K102248 000
M711E2S75300 K102248 000
M711E2S75350 K102248 000
M711E2S75400 K102248 000
M711E2S75450 K102248 000
M711E2S75500 K102248 000
M711E355550 K102248 000
M711E365250 K102248 000
M711E385600 K102248 000
M711LA1830 K102248 000
M711LS1890 K102248 000
M711LS1930 K102248 000
M711LS1940 K102248 000
M711LS2080 K102248 000
M711LS2120 K102248 000
M711LS2180 K102248 000
M711E2S65300 K102248 000
M711LS1470 K102248 000
M711LS1530 K102248 000
M711LS1600 K102248 000
M711LS1750 K102248 000
M711LS5630 K102248 000
M711LS5640 K102248 000
M711LS5670 K102248 000
M711LS5680 K102248 000
M711E385550 K102248 000
M711E385500 K102248 000
M711E385450 K102248 000
M711E365300 K102248 000
M711E365350 K102248 000
M711E365400 K102248 000
M711E365450 K102248 000
M711E365500 K102248 000
M711E365550 K102248 000
M711E365600 K102248 000
M711E375300 K102248 000
M711E375350 K102248 000
M711E375400 K102248 000
M711E375450 K102248 000
M711E375500 K102248 000
M711E375550 K102248 000
M711E375600 K102248 000
M711E385300 K102248 000
M711E385350 K102248 000
M711E385400 K102248 000
M711LS3510 K102248 000
M711E2S55250 K102248 000
M711ECC75350 K102248 000
M711EM65450 K102248 000
M711EM65500 K102248 000
M711EM65550 K102248 000
M711EM65600 K102248 000
M711EM75300 K102248 000
M711EM75350 K102248 000
M711EM75400 K102248 000
M711EM75450 K102248 000
M711EM75500 K102248 000
M711EM75550 K102248 000
M711EM75600 K102248 000
M711CL30300 K102248 000
M711CL35350 K102248 000
M711CL39450 K102248 000
M711CL45570 K102248 000
M711CL57810 K102248 000
M711E20020 K102248 000
M711EM65400 K102248 000
M711EM65350 K102248 000
M711EM65300 K102248 000
M711ECC75400 K102248 000
M711ECC75450 K102248 000
M711ECC75500 K102248 000
M711ECC75550 K102248 000
M711ECC75600 K102248 000
M711EM475250 K102248 000
M711EM475300 K102248 000
M711EM475350 K102248 000
M711EM475400 K102248 000
M711EM475450 K102248 000
M711EM55300 K102248 000
M711EM55350 K102248 000
M711EM55400 K102248 000
M711EM55450 K102248 000
M711EM55500 K102248 000
M711EM55550 K102248 000
M711EM65250 K102248 000
M711E20024 K102248 000
M711E2475250 K102248 000
M711E275350 K102248 000
M711E275400 K102248 000
M711E275450 K102248 000
M711E275500 K102248 000
M711E275550 K102248 000
M711E275600 K102248 000
M711E285300 K102248 000
M711E285350 K102248 000
M711E285400 K102248 000
M711E285450 K102248 000
M711E285500 K102248 000
M711E285550 K102248 000
M711E285600 K102248 000
M711E2S475250 K102248 000
M711E2S475300 K102248 000
M711E2S475350 K102248 000
M711E2S475400 K102248 000
M711E275300 K102248 000
M711E265600 K102248 000
M711E265550 K102248 000
M711E2475300 K102248 000
M711E2475350 K102248 000
M711E2475400 K102248 000
M711E2475450 K102248 000
M711E255250 K102248 000
M711E255300 K102248 000
M711E255350 K102248 000
M711E255400 K102248 000
M711E255450 K102248 000
M711E255500 K102248 000
M711E255550 K102248 000
M711E265250 K102248 000
M711E265300 K102248 000
M711E265350 K102248 000
M711E265400 K102248 000
M711E265450 K102248 000
M711E265500 K102248 000
M711E2S475450 K102248 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.