Navigation Module of the Cortium® System— 510(k) K252087
Substantially EquivalentUlrich Medical USA, Inc.
FDA 510(k) clearance K252087 for Navigation Module of the Cortium® System, Substantially Equivalent on 2026-02-03. Applicant: Ulrich Medical USA, Inc.. Device class: 2.
Summary
Ulrich Medical USA's Navigation Module of the Cortium® System is filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the module beyond its name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Ulrich Medical USA filed from Plano, Texas. The decision came 216 calendar days after FDA received it (July 2, 2025 to February 3, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Ulrich Medical USA, Inc.
- 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
- Traditional
- Location
- Plano, TX, US
Recent devices under product code OLO
view allMore clearances from Ulrich Medical USA, Inc.
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.