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: K181440
• 510k Number: K181440
• 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. 3 Enterprise Drive, Suite 210 Shelton, CT 06484
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-01
• Decision Date: 2018-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840642160765	K181440	000
10840642131376	K181440	000
10840642131352	K181440	000
10840642131338	K181440	000
10840642131314	K181440	000
10840642131291	K181440	000
10840642131277	K181440	000
10840642131253	K181440	000
10840642130850	K181440	000
10840642130737	K181440	000
10840642130676	K181440	000
10840642130614	K181440	000
10840642131390	K181440	000
10840642131413	K181440	000
10840642131437	K181440	000
10840642132281	K181440	000
10840642131628	K181440	000
10840642131604	K181440	000
10840642131581	K181440	000
10840642131567	K181440	000
10840642131543	K181440	000
10840642131529	K181440	000
10840642131505	K181440	000
10840642131482	K181440	000
10840642131468	K181440	000
10840642131444	K181440	000
10840642130553	K181440	000