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

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..

Clearance details

Applicant: Remex Medical Corp.
Product code: Code OLO
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 ↗

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.