SEURAT™ Universal Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

CTL Medical Corporation

The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Seurat™ Universal Pedicle Screw System.

Pre-market Notification Details

• Device ID: K173185
• 510k Number: K173185
• Device Name: SEURAT™ Universal Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: CTL Medical Corporation 4550 Excel Parkway, Suite 300 Addison, TX 75001
• Contact: Tosan Onosode
• Correspondent: Barry E. Sands; RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913
• 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: 2017-09-29
• Decision Date: 2018-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841732129986	K173185	000
00841732129849	K173185	000
00841732129856	K173185	000
00841732129863	K173185	000
00841732129870	K173185	000
00841732129887	K173185	000
00841732129894	K173185	000
00841732129900	K173185	000
00841732129917	K173185	000
00841732129924	K173185	000
00841732129931	K173185	000
00841732129948	K173185	000
00841732129955	K173185	000
00841732129962	K173185	000
00841732129979	K173185	000
00841732129795	K173185	000