LigaPASS® Spinal System, CD Horizon™ Spinal System

Bone Fixation Cerclage, Sublaminar

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Ligapass® Spinal System, Cd Horizon™ Spinal System.

Pre-market Notification Details

• Device ID: K211057
• 510k Number: K211057
• Device Name: LigaPASS® Spinal System, CD Horizon™ Spinal System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: Medtronic, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Taylor Gold West
• Correspondent: Shweta Sharma; Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132
• Product Code: OWI
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-09
• Decision Date: 2021-05-27