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Autobahn 1257.1132

by Globus Medical, Inc.

Autobahn 1257.1132 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K220659 on 9 Sep 2022 and listed in FDA GUDID since 14 Aug 2026 (UDI-DI 00193982471767), active as of 23 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 23 Oct 2026

Documents

510(k) K220659

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193982471767 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220659 Date9 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220659 decided 9 Sep 2022 Active
  • FDA GUDID UDI-DI 00193982471767 listed 14 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220659
  2. Listed FDA GUDID 00193982471767

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Autobahn
Generic name
Femur intramedullary nail
Model / Ref / Catalog
1257.1132
Primary DI / UDI-DI
00193982471767
510(k) Number
FDA product code
HWC, HSB, JDS
GMDN term
Femur intramedullary nail
Device class
Class II
Regulation number
888.3040, 888.3020, 888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 320.0 Millimeter
Outer Diameter — 11.0 Millimeter

Related devices

Cleared under the same submission (K220659)

and 8 more cleared under K220659

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)