DuraPro™ Oscillating System

by Globus Medical, Inc.

510(k) K240568

DuraPro™ Oscillating System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K240568 on 29 Apr 2024, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

510(k) K240568↗

FDA record

Trust

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK240568	Date29 Apr 2024Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K240568

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K240568
FDA product code: OLO

Device class: Class II
Regulation: 21 CFR Part 882.4560
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

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