AUTOBAHN™ Nailing System

by Globus Medical, Inc.

510(k) K261043

AUTOBAHN™ Nailing System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K261043 on 24 Apr 2026, 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) K261043↗

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 · Special	NumberK261043	Date24 Apr 2026Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K261043

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K261043
FDA product code: HSB

Device class: Class II
Regulation: 21 CFR Part 888.3020
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →