CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody— 510(k) K254157
Substantially EquivalentMedos International SARL
FDA 510(k) clearance K254157 for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody, Substantially Equivalent on 2026-05-26. Applicant: Medos International SARL. Device class: 2.
Summary
Medos International's CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody are filed under OLO, orthopedic stereotaxic instruments.
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.
Medos filed from Le Locle, Switzerland. Review took 155 calendar days (December 22, 2025 to May 26, 2026).
Clearance details
- Applicant
- Medos International SARL
- 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
- Le Locle, CH
Recent devices under product code OLO
view allMore clearances from Medos International SARL
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.