Medical Device Manufacturer · KR , Seoul

GS Medical Co., Ltd. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2006

Recent clearances: AnyPlus II Spinal Fixation System, The VEGA Cervical Screw System, AnyPlus Navigated Instruments System

20
Total
20
Cleared
0
Denied

FDA 510(k) Regulatory Record - GS Medical Co., Ltd. Orthopedic ✕

20 devices
1-12 of 20
Cleared Oct 02, 2026
AnyPlus II Spinal Fixation System
K261217 · NKB
Orthopedic · 171d
Cleared Sep 17, 2026
The VEGA Cervical Screw System
K254260 · NKG
Orthopedic · 262d
Cleared Dec 06, 2024
AnyPlus Navigated Instruments System
K243073 · OLO
Orthopedic · 70d
Cleared Aug 20, 2024
PYXIS 3D Titanium Cervical Cage system
K241738 · ODP
Orthopedic · 64d
Cleared Apr 03, 2024
AnyPlus II Spinal Fixation System
K240350 · NKB
Orthopedic · 58d
Cleared Jul 20, 2023
QUASAR Standalone ACIF System
K231808 · OVE
Orthopedic · 30d
Cleared Apr 26, 2023
PYXIS 3D Titanium Cage System
K223868 · MAX
Orthopedic · 124d
Cleared Feb 09, 2023
CYGNUS-C Standalone ACIF System
K222041 · OVE
Orthopedic · 213d
Cleared Jul 27, 2022
Pegasus-X Expandable PLIF System
K221687 · MAX
Orthopedic · 47d
Cleared Oct 28, 2021
TRACKER Plus Kyphoplasty System
K211797 · NDN
Orthopedic · 140d
Cleared Aug 10, 2020
GS Medical AnyPlus PEEK Cage System
K200592 · ODP
Orthopedic · 157d
Cleared Dec 04, 2019
TRACKER Kyphoplasty System
K192335 · NDN
Orthopedic · 98d
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