Ibis® Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Ibis® Pedicle Screw System.

Pre-market Notification Details

• Device ID: K162995
• 510k Number: K162995
• Device Name: Ibis® Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Contact: Lindsay Martin
• Correspondent: Lindsay Martin; Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-27
• Decision Date: 2017-03-30
• Summary: summary