HILINE™ Fixation System

by Globus Medical, Inc.

510(k) K230565

HILINE™ Fixation System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K230565 on 20 Apr 2023, 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) K230565↗

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	NumberK230565	Date20 Apr 2023Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K230565

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K230565
FDA product code: OWI

Device class: Class II
Regulation: 21 CFR Part 888.3010
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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