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E-GPS Navigated Instruments

Precision Spine, 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

3

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K220862
Device name
E-GPS Navigated Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-03-24
Decision date
2022-07-14
Submission type
Traditional
Technology type
Robotic Navigation(AI inferred)
Clinical applications
Spine SurgeryNavigation SystemRobotic Assistance
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for use as an aid for precisely locating anatomical structures and for the special 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. Use of the E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti, Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).

Intended Use

The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for use as an aid for precisely locating anatomical structures and for the special 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. Use of the E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti, Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).

Device Description

Precision Spine E-GPS Navigated Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899.

Summary parsed at:2026-06-24 04:34:23 UTC

Predicate devices

3

K220862 references 3 predicate/reference devices

Cited as predicate

4

4 submissions cite K220862 as a predicate