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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