Manufacturer
Spine Wave, Inc.Salvo® Robotic Navigation Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243514
- Device name
- Salvo® Robotic Navigation Instruments
- Company
- Spine Wave, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-11-13
- Decision date
- 2025-04-03
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, which 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.
Intended Use
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, which 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.
Device Description
The Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's Excelsius GPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered non-sterile to be cleaned and steam sterilized by the end user.
Summary parsed at:2026-06-19 05:20:05 UTC
Predicate devices
2—
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Not ingested
E-GPS Navigated Instruments
K243514 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K243514 as a predicate
