AnyPlus® Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

GS Medical Co., Ltd.

The following data is part of a premarket notification filed by Gs Medical Co., Ltd. with the FDA for Anyplus® Spinal Fixation System.

Pre-market Notification Details

• Device ID: K172546
• 510k Number: K172546
• Device Name: AnyPlus® Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: GS Medical Co., Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun, KR 363-951
• Contact: Marcin Niemiec
• 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: 2017-08-23
• Decision Date: 2017-10-23
• Summary: summary