Autobahn 1176.0100

by Globus Medical, Inc.

Autobahn 1176.0100 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K171108 on 29 Dec 2017 and listed in FDA GUDID since 19 Apr 2021 (UDI-DI 00889095441086), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889095441086 UDI-DI	Date19 Apr 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171108	Date29 Dec 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889095441086
FDA 510(k) database 510(k) number K171108

Across registries

2 registries list this device

FDA 510(k) K171108 decided 29 Dec 2017 Active
FDA GUDID UDI-DI 00889095441086 listed 19 Apr 2021 Listed

Timeline

2 dated events

29 Dec 2017 Cleared FDA 510(k) K171108
19 Apr 2021 Listed FDA GUDID 00889095441086

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Autobahn
Generic name: Arthrodesis intramedullary nail, non-distracting
Model / reference: 1176.0100

Primary DI / UDI-DI: 00889095441086
510(k) Number: K171108
FDA product code: JDS, HWC, HSB
GMDN term: Arthrodesis intramedullary nail, non-distracting

Device class: Class II
Regulation number: 888.3030, 888.3040, 888.3020
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

Sterilise before use
Single use
Implantable
Lot / batch number

Other properties (11, all answered No)