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FDA 510(k) Applications Submitted by GS Medical Co. Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211797
06/10/2021
TRACKER Plus Kyphoplasty System
GS Medical Co. Ltd.
K221687
06/10/2022
Pegasus-X Expandable PLIF System
GS Medical Co. Ltd.
K222041
07/11/2022
CYGNUS-C Standalone ACIF System
GS Medical Co. Ltd.
K223868
12/23/2022
PYXIS 3D Titanium Cage System
GS Medical Co. Ltd.
K231808
06/20/2023
QUASAR Standalone ACIF System
GS Medical Co. Ltd.
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