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 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

NIH GUDID Devices

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