Salvo™ Spine System

Thoracolumbosacral Pedicle Screw System

Spine Wave, Inc.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Salvo™ Spine System.

Pre-market Notification Details

• Device ID: K191045
• 510k Number: K191045
• Device Name: Salvo™ Spine System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484
• Contact: Amy Noccioli
• Correspondent: Amy Noccioli; Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-19
• Decision Date: 2019-07-10