EXCELLA III-D SPINAL DEFORMITY SYSTEM

Thoracolumbosacral Pedicle Screw System

INNOVASIS, INC.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Excella Iii-d Spinal Deformity System.

Pre-market Notification Details

• Device ID: K140238
• 510k Number: K140238
• Device Name: EXCELLA III-D SPINAL DEFORMITY SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107
• Contact: Mashall Mccarty
• Correspondent: Mashall Mccarty; INNOVASIS, INC. 614 E 3900 S 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-30
• Decision Date: 2014-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711E3S75350	K140238	000
M711E3S55250	K140238	000
M711E3HP9900	K140238	000
M711E3HP9750	K140238	000
M711E3HL9900	K140238	000
M711E3HL9750	K140238	000
M711E3HL9600	K140238	000
M711E3HL7900	K140238	000
M711E3HL7750	K140238	000
M711E3HL7600	K140238	000
M711E3HE9750	K140238	000
M711E3HA775R0	K140238	000
M711E3HA775L0	K140238	000
M711UCL25250	K140238	000
M711E3S55300	K140238	000
M711E3S55350	K140238	000
M711E3S75300	K140238	000
M711E3S65600	K140238	000
M711E3S65550	K140238	000
M711E3S65500	K140238	000
M711E3S65450	K140238	000
M711E3S65400	K140238	000
M711E3S65350	K140238	000
M711E3S65300	K140238	000
M711E3S65250	K140238	000
M711E3S55550	K140238	000
M711E3S55500	K140238	000
M711E3S55450	K140238	000
M711E3S55400	K140238	000
M711UCL20200	K140238	000
M711SR555000	K140238	000
M711RC556050	K140238	000
M711RC556040	K140238	000
M711RC556030	K140238	000
M711RC556020	K140238	000
M711RC556010	K140238	000
M711OC55450	K140238	000
M711OC55350	K140238	000
M711OC55250	K140238	000
M711LS473020	K140238	000
M711LS473010	K140238	000
M711LS4720	K140238	000
M711LS4710	K140238	000
M711LS4700	K140238	000
M711RE355300	K140238	000
M711RE355350	K140238	000
M711RE375500	K140238	000
M711RE375450	K140238	000
M711RE375400	K140238	000
M711RE375350	K140238	000
M711RE375300	K140238	000
M711RE365500	K140238	000
M711RE365450	K140238	000
M711RE365400	K140238	000
M711RE365350	K140238	000
M711RE365300	K140238	000
M711RE355500	K140238	000
M711RE355450	K140238	000
M711RE355400	K140238	000
M711E2L85900	K140238	000
M711E3RC556000	K140238	000
M711E2L65700	K140238	000
M711E2L651000	K140238	000
M711E3U75550	K140238	000
M711E3U75500	K140238	000
M711E3U75450	K140238	000
M711E3U75400	K140238	000
M711E3U75350	K140238	000
M711E3U75300	K140238	000
M711E3U65550	K140238	000
M711E3U65500	K140238	000
M711E3U65450	K140238	000
M711E3U65400	K140238	000
M711E3U65350	K140238	000
M711E2L65800	K140238	000
M711E2L65900	K140238	000
M711E3RC555000	K140238	000
M711E2S40450	K140238	000
M711E2S40400	K140238	000
M711E2S40350	K140238	000
M711E2S40300	K140238	000
M711E2S40250	K140238	000
M711E2L85800	K140238	000
M711E2L85700	K140238	000
M711E2L851000	K140238	000
M711E2L75900	K140238	000
M711E2L75800	K140238	000
M711E2L75700	K140238	000
M711E2L751000	K140238	000
M711E3U65300	K140238	000
M711E3U65250	K140238	000
M711E3U40300	K140238	000
M711E3U40250	K140238	000
M711E3S85600	K140238	000
M711E3S85550	K140238	000
M711E3S85500	K140238	000
M711E3S85450	K140238	000
M711E3S85400	K140238	000
M711E3S85350	K140238	000
M711E3S85300	K140238	000
M711E3S75600	K140238	000
M711E3S75550	K140238	000
M711E3S75500	K140238	000
M711E3S75450	K140238	000
M711E3U40350	K140238	000
M711E3U40400	K140238	000
M711E3U55550	K140238	000
M711E3U55500	K140238	000
M711E3U55450	K140238	000
M711E3U55400	K140238	000
M711E3U55350	K140238	000
M711E3U55300	K140238	000
M711E3U55250	K140238	000
M711E3U475450	K140238	000
M711E3U475400	K140238	000
M711E3U475350	K140238	000
M711E3U475300	K140238	000
M711E3U475250	K140238	000
M711E3U40450	K140238	000
M711E3S75400	K140238	000