Elsa 1122.0460

by Globus Medical, Inc.

Elsa 1122.0460 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K161379 on 29 Sep 2016 and listed in FDA GUDID since 24 Jan 2021 (UDI-DI 00889095258103), 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	Number00889095258103 UDI-DI	Date24 Jan 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK161379	Date29 Sep 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889095258103
FDA 510(k) database 510(k) number K161379

Across registries

2 registries list this device

FDA 510(k) K161379 decided 29 Sep 2016 Active
FDA GUDID UDI-DI 00889095258103 listed 24 Jan 2021 Listed

Timeline

2 dated events

29 Sep 2016 Cleared FDA 510(k) K161379
24 Jan 2021 Listed FDA GUDID 00889095258103

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Elsa
Generic name: Metallic spinal interbody fusion cage
Model / reference: 1122.0460

Primary DI / UDI-DI: 00889095258103
510(k) Number: K161379
FDA product code: OVD, MAX
GMDN term: Metallic spinal interbody fusion cage

Device class: Class II
Regulation number: 888.3080
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Single use
Implantable
Lot / batch number

Other properties (11, all answered No)