The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella Ii Spinal System Model Ec2-00.
Device ID | K102248 |
510k Number | K102248 |
Device Name: | EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
Contact | Marshall C Mccarty |
Correspondent | Marshall C Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-09 |
Decision Date | 2010-10-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |