Remex Spine Surgery Navigation - Universal Instruments— 510(k) K262506
Substantially EquivalentRemex Medical Corp.
FDA 510(k) clearance K262506 for Remex Spine Surgery Navigation - Universal Instruments, Substantially Equivalent on 2026-08-20. Applicant: Remex Medical Corp.. Device class: 2.
Summary
Remex Medical's Remex Spine Surgery Navigation - Universal Instruments is filed under product code OLO, orthopedic stereotaxic instruments. The record gives no model numbers.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.
Remex filed from Taichung, Taiwan. FDA found it substantially equivalent 30 calendar days after receipt (July 21 to August 20, 2026).
Clearance details
- Applicant
- Remex Medical Corp.
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taichung, TW
Recent devices under product code OLO
view all- K263154 — CarboClear® Cervical Navigated Instruments
- K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
- K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- K261205 — SPINEART Navigation Instrument System
- K261024 — TMINI Miniature Robotic System
More clearances from Remex Medical Corp.
view allAdverse 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, through . 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.