Px 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.

Pre-market Notification Details

• Device ID: K150500
• 510k Number: K150500
• Device Name: Px 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: 2015-02-26
• Decision Date: 2015-06-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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