ADIRA™ Lateral Plate System

by Globus Medical, Inc.

510(k) K233735

ADIRA™ Lateral Plate System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K233735 on 25 Jan 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) K233735↗

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	NumberK233735	Date25 Jan 2024Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K233735

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K233735
FDA product code: KWQ

Device class: Class II
Regulation: 21 CFR Part 888.3060
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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