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510(k) K243073

AnyPlus Navigated Instruments System by GS Medical Co., Ltd. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2024
Date Received
September 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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  • K223868 — PYXIS 3D Titanium Cage System (April 26, 2023)
  • K222041 — CYGNUS-C Standalone ACIF System (February 9, 2023)
  • K221687 — Pegasus-X Expandable PLIF System (July 27, 2022)
  • K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)
  • K200592 — GS Medical AnyPlus PEEK Cage System (August 10, 2020)
  • K192335 — TRACKER Kyphoplasty System (December 4, 2019)
  • K190170 — MVP Cervical Plate System (May 13, 2019)

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