Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II— 510(k) K251315

Name: FDA 510(k) clearance K251315
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Substantially Equivalent

Remex Medical Corp.

FDA 510(k) clearance K251315 for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, Substantially Equivalent on 2025-05-29. Applicant: Remex Medical Corp.. Device class: 2.

Clearance details

Applicant: Remex Medical Corp.
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-04-29
Decision date: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Remex Medical Corp.

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K243560 — Remex Spine Surgery Navigation Instrument2024-12-13
K241625 — Anatase Navi Disposable Instrument2024-07-05
K233513 — Remex Spine Surgery Navigation System II2024-05-01
K230783 — Anatase Spine Surgery Navigation System2023-04-21

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.