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 IDK172546
510k NumberK172546
Device Name:AnyPlus® Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant GS Medical Co., Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun,  KR 363-951
ContactMarcin Niemiec
CorrespondentBarry E. Sands
RQMIS Inc. 110 Haverhill Road, Suite 526 Amesbury,  MA  01913
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-23
Decision Date2017-10-23
Summary:summary

Trademark Results [AnyPlus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANYPLUS
ANYPLUS
97686804 not registered Live/Pending
Shenzhen Hongjing Industrial Co., Ltd.
2022-11-21
ANYPLUS
ANYPLUS
77648459 3775938 Live/Registered
GS Medical Co., Ltd.
2009-01-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.