Gibralt® Spine System And Gibralt® Occipital Spine System

Posterior Cervical Screw System

Exactech, Inc.

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

Pre-market Notification Details

• Device ID: K160697
• 510k Number: K160697
• Device Name: Gibralt® Spine System And Gibralt® Occipital Spine System
• Classification: Posterior Cervical Screw System
• Applicant: Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653
• Contact: Dawn Davisson
• Correspondent: Kenneth C. Maxwell; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-14
• Decision Date: 2016-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996170017	K160697	000
00840996169936	K160697	000
00840996169943	K160697	000
00840996169950	K160697	000
00840996169967	K160697	000
00840996169974	K160697	000
00840996169981	K160697	000
00840996169998	K160697	000
00840996170000	K160697	000
00840996169929	K160697	000