CapSure® PS 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 Capsure® Ps System.

Pre-market Notification Details

• Device ID: K172175
• 510k Number: K172175
• Device Name: CapSure® PS 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. Three Enterprise Drive, Suite 210 Shelton, CT 06484
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-19
• Decision Date: 2017-08-16
• Summary: summary