Excelsiusgps 6255.2205

by Globus Medical, Inc.

Excelsiusgps 6255.2205 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K191100 on 24 Jul 2019 and listed in FDA GUDID since 1 Dec 2024 (UDI-DI 00193982618711), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00193982618711 UDI-DI	Date1 Dec 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK191100	Date24 Jul 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00193982618711
FDA 510(k) database 510(k) number K191100

Across registries

2 registries list this device

FDA 510(k) K191100 decided 24 Jul 2019 Active
FDA GUDID UDI-DI 00193982618711 listed 1 Dec 2024 Listed

Timeline

2 dated events

24 Jul 2019 Cleared FDA 510(k) K191100
1 Dec 2024 Listed FDA GUDID 00193982618711

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Excelsiusgps
Generic name: Robotic surgical navigation system
Model / reference: 6255.2205

Primary DI / UDI-DI: 00193982618711
510(k) Number: K191100
FDA product code: OLO
GMDN term: Robotic surgical navigation system

Device class: Class II
Regulation number: 882.4560
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Lot / batch number

Other properties (13, all answered No)