GS Medical Co., Ltd. is one of 440 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
GS Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: AnyPlus II Spinal Fixation System, The VEGA Cervical Screw System, AnyPlus Navigated Instruments System
20
Total
20
Cleared
0
Denied
GS Medical Co., Ltd. has 20 FDA 510(k) cleared orthopedic devices. Based in Seoul, KR.
Latest FDA clearance: Oct 2026. Active since 2006.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by RQMIS, Inc. and Rqmis.
FDA 510(k) Regulatory Record - GS Medical Co., Ltd.
20 devices
Cleared
Oct 02, 2026
AnyPlus II Spinal Fixation System
Orthopedic
171d
Cleared
Sep 17, 2026
The VEGA Cervical Screw System
Orthopedic
262d
Cleared
Dec 06, 2024
AnyPlus Navigated Instruments System
Orthopedic
70d
Cleared
Aug 20, 2024
PYXIS 3D Titanium Cervical Cage system
Orthopedic
64d
Cleared
Apr 03, 2024
AnyPlus II Spinal Fixation System
Orthopedic
58d
Cleared
Jul 20, 2023
QUASAR Standalone ACIF System
Orthopedic
30d
Cleared
Apr 26, 2023
PYXIS 3D Titanium Cage System
Orthopedic
124d
Cleared
Feb 09, 2023
CYGNUS-C Standalone ACIF System
Orthopedic
213d
Cleared
Jul 27, 2022
Pegasus-X Expandable PLIF System
Orthopedic
47d
Cleared
Oct 28, 2021
TRACKER Plus Kyphoplasty System
Orthopedic
140d
Cleared
Aug 10, 2020
GS Medical AnyPlus PEEK Cage System
Orthopedic
157d
Cleared
Dec 04, 2019
TRACKER Kyphoplasty System
Orthopedic
98d