Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

Intervertebral Fusion Device With Bone Graft, Lumbar

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Px Peek Ibf System, Px Ha Peek Ibf System, Txha Peek Ibf System.

Pre-market Notification Details

• Device ID: K180078
• 510k Number: K180078
• Device Name: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Contact: Marshall Mccarty
• Correspondent: Marshall Mccarty; Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-10
• Decision Date: 2018-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711TX101428101	K180078	000
M711LS43312100	K180078	000
M711LS43312050	K180078	000
M711LS43311120	K180078	000
M711LS43311100	K180078	000
M711LS43311050	K180078	000
M711LS43310120	K180078	000
M711LS43310100	K180078	000
M711LS43310050	K180078	000
M711LS43309120	K180078	000
M711LS43309100	K180078	000
M711LS43309050	K180078	000
M711LS43312120	K180078	000
M711LS43313050	K180078	000
M711LS43316120	K180078	000
M711LS43316100	K180078	000
M711LS43316050	K180078	000
M711LS43315120	K180078	000
M711LS43315100	K180078	000
M711LS43315050	K180078	000
M711LS43314120	K180078	000
M711LS43314100	K180078	000
M711LS43314050	K180078	000
M711LS43313120	K180078	000
M711LS43313100	K180078	000
M711LS43308050	K180078	000
M711LS39716120	K180078	000
M711LS39716100	K180078	000
M711LS39711120	K180078	000
M711LS39711100	K180078	000
M711LS39711050	K180078	000
M711LS39710120	K180078	000
M711LS39710100	K180078	000
M711LS39710050	K180078	000
M711LS39709120	K180078	000
M711LS39709100	K180078	000
M711LS39709050	K180078	000
M711LS39708100	K180078	000
M711LS39708050	K180078	000
M711LS39712050	K180078	000
M711LS39712100	K180078	000
M711LS39716050	K180078	000
M711LS39715120	K180078	000
M711LS39715100	K180078	000
M711LS39715050	K180078	000
M711LS39714120	K180078	000
M711LS39714100	K180078	000
M711LS39714050	K180078	000
M711LS39713120	K180078	000
M711LS39713100	K180078	000
M711LS39713050	K180078	000
M711LS39712120	K180078	000
M711LS39707050	K180078	000
M711TX121633121	K180078	000
M711LS4490	K180078	000
M711TX101028101	K180078	000
M711TX101028051	K180078	000
M711TX100928121	K180078	000
M711TX100928101	K180078	000
M711TX100928051	K180078	000
M711TX100828101	K180078	000
M711TX100828051	K180078	000
M711TX100728051	K180078	000
M711TX121633101	K180078	000
M711TX121633051	K180078	000
M711TX121533121	K180078	000
M711TX101028121	K180078	000
M711TX101128051	K180078	000
M711LS3960	K180078	000
M711LS3950	K180078	000
M711TX101428051	K180078	000
M711TX101328121	K180078	000
M711TX101328101	K180078	000
M711TX101328051	K180078	000
M711TX101228121	K180078	000
M711TX101228101	K180078	000
M711TX101228051	K180078	000
M711TX101128121	K180078	000
M711TX101128101	K180078	000
M711TX121533101	K180078	000
M711TX121533051	K180078	000
M711TX121433121	K180078	000
M711TX121033050	K180078	000
M711TX120933121	K180078	000
M711TX120933101	K180078	000
M711TX120933050	K180078	000
M711TX120833051	K180078	000
M711TX101628121	K180078	000
M711TX101628101	K180078	000
M711TX101628051	K180078	000
M711TX101528121	K180078	000
M711TX101528101	K180078	000
M711TX101528051	K180078	000
M711TX121033101	K180078	000
M711TX121033121	K180078	000
M711TX121433101	K180078	000
M711TX121433051	K180078	000
M711TX121333121	K180078	000
M711TX121333101	K180078	000
M711TX121333051	K180078	000
M711TX121233121	K180078	000
M711TX121233101	K180078	000
M711TX121233051	K180078	000
M711TX121133121	K180078	000
M711TX121133101	K180078	000
M711TX121133051	K180078	000
M711TX101428121	K180078	000