Innovasis Gibralt Spine System

Posterior Cervical Screw System

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Innovasis Gibralt Spine System.

Pre-market Notification Details

• Device ID: K192354
• 510k Number: K192354
• Device Name: Innovasis Gibralt Spine System
• Classification: Posterior Cervical Screw System
• Applicant: Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Contact: Marshall Mccarthy
• Correspondent: Marshall Mccarthy; Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-29
• Decision Date: 2019-09-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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