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510(k) K230783

Anatase Spine Surgery Navigation System by Remex Medical Corp. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2023
Date Received
March 22, 2023
Clearance Type
Special
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.

Other clearances by Remex Medical Corp.

  • K251315 — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation Syste (May 29, 2025)
  • K243560 — Remex Spine Surgery Navigation Instrument (December 13, 2024)
  • K241625 — Anatase Navi Disposable Instrument (July 5, 2024)
  • K233513 — Remex Spine Surgery Navigation System II (May 1, 2024)

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  • K253444 — EUROPA™ Posterior Cervical Fusion Navigated Instruments (March 18, 2026)
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  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
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