Benchmed logo
Categories

ExcelsiusGPS™ Instruments

Globus Medical, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

10

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250599
Device name
ExcelsiusGPS™ Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-02-28
Decision date
2025-11-05
Submission type
Traditional
Technology type
Software Navigation(AI inferred)
Clinical applications
Spine SurgeryNavigation SystemOther
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

ExcelsiusGPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

Intended Use

ExcelsiusGPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

Device Description

Subject ExcelsiusGPS™ instruments consist of verification adapters and surgical instruments, including interbody inserters and trials, that may be used manually or navigated with the use of ExcelsiusGPS™ or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

Summary parsed at:2026-06-19 05:21:11 UTC

Predicate devices

10

K250599 references 10 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K250599 as a predicate