Infinity™ OCT System, PASS OCT® Spinal System

Posterior Cervical Screw System

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Infinity™ Oct System, Pass Oct® Spinal System.

Pre-market Notification Details

• Device ID: K210449
• 510k Number: K210449
• Device Name: Infinity™ OCT System, PASS OCT® Spinal System
• Classification: Posterior Cervical Screw System
• Applicant: Medtronic 1800 Pyramid Place Memphis, TN 38132
• Contact: Shweta Sharma
• Correspondent: Shweta Sharma; Medtronic 1800 Pyramid Place Memphis, TN 38132
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-16
• Decision Date: 2021-03-18