CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
Summary
Medos International SARL received 510(k) clearance for CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody, a OLO device. Cleared on 2026-05-26.
Details
Source
510(k) Clearance
External ID
K254157
Action Date
2026-05-26
Status
Traditional
Category
device
Product Code
OLO
Product Description
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody. Product code: OLO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medos International SARL has received 21 total clearances in our database.
Medos International SARL has 22 FDA actions in our database, including 1 recall and 21 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medos International SARL have FDA actions?
Medos International SARL has 22 FDA actions in our database, including 1 recall and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K254157" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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