Medical Device Manufacturer · KR , Seoul

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

18 submissions · 18 cleared · Since 2006
18
Total
18
Cleared
0
Denied

GS Medical Co., Ltd. has 18 FDA 510(k) cleared orthopedic devices. Based in Seoul, KR.

Latest FDA clearance: Dec 2024. 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.

510(k) submissions have been managed by RQMIS, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - GS Medical Co., Ltd.
18 devices
1-18 of 18
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
Cleared May 13, 2019
MVP Cervical Plate System
K190170 · KWQ
Orthopedic · 101d
Cleared Oct 23, 2017
AnyPlus® Spinal Fixation System
K172546 · NKB
Orthopedic · 61d
Cleared Jun 24, 2016
AnyPlus® Cervical PEEK Cage System
K153517 · ODP
Orthopedic · 199d
Cleared Apr 18, 2014
ANYPLUS
K131612 · MAX
Orthopedic · 319d
Cleared Oct 17, 2011
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
K111354 · MAX
Orthopedic · 157d
Cleared Dec 03, 2010
ANYPLUS PEEK CAGES
K100516 · OVD
Orthopedic · 283d
Cleared Jan 25, 2010
ANY PLUS SPINAL FIXATION SYSTEM
K091717 · NKB
Orthopedic · 228d
Cleared Mar 08, 2006
GSS PEDICLE SCREW SYSTEM
K053573 · MNH
Orthopedic · 76d
Filters
All18 Orthopedic 18