Vitality® Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Zimmer Biomet Spine, Inc.

The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Vitality® Spinal Fixation System.

Pre-market Notification Details

• Device ID: K203507
• 510k Number: K203507
• Device Name: Vitality® Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021
• Contact: Alex Pawlowski
• Correspondent: Alex Pawlowski; Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-30
• Decision Date: 2021-01-28