Kestrel™ Buttress Plate System

Appliance, Fixation, Spinal Intervertebral Body

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Kestrel™ Buttress Plate System.

Pre-market Notification Details

• Device ID: K181063
• 510k Number: K181063
• Device Name: Kestrel™ Buttress Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• 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: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-23
• Decision Date: 2018-07-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711LS4340	K181063	000
M711BTA1580	K181063	000
M711UT65200	K181063	000
M711UT55300	K181063	000
M711UT55250	K181063	000
M711UT55200	K181063	000
M711UT280	K181063	000
M711UT240	K181063	000
M711UT200	K181063	000