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Autobahn 1257.0205S

by Globus Medical, Inc.

Autobahn 1257.0205S 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 28 Mar 2023 (UDI-DI 00193982488468), 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 Number00193982488468 UDI-DI Date28 Mar 2023ListedStatusListed 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 00193982488468 listed 28 Mar 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220659
  2. Listed FDA GUDID 00193982488468

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  • Withdrawn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
Bone nail implantable cap
Model / reference
1257.0205S
Primary DI / UDI-DI
00193982488468
510(k) Number
FDA product code
HWC, HSB, JDS
GMDN term
Bone nail implantable cap
Device class
Class II
Regulation number
888.3040, 888.3020, 888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone nail end-cap

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

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)