Proficient® Posterior Cervical Spine System

Posterior Cervical Screw System

Spine Wave, Inc.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Proficient® Posterior Cervical Spine System.

Pre-market Notification Details

• Device ID: K172594
• 510k Number: K172594
• Device Name: Proficient® Posterior Cervical Spine System
• Classification: Posterior Cervical 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: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-29
• Decision Date: 2017-12-15
• Summary: summary