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510(k) K251315

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2025
Date Received
April 29, 2025
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.

  • 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)
  • K230783 — Anatase Spine Surgery Navigation System (April 21, 2023)

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  • K252037 — CUVIS-joint (CJ150) (March 25, 2026)
  • K253604 — TiLink-L Navigation Instruments (March 20, 2026)
  • K253444 — EUROPA™ Posterior Cervical Fusion Navigated Instruments (March 18, 2026)
  • K260546 — Q Pedicle Instruments (March 17, 2026)
  • K260010 — TMINI® Miniature Robotic System (March 3, 2026)
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