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Spine Navigation and Robotic-Assistance Device

Ecential Robotics

Country / Region:France (FR)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

Ecential Robotics
France (FR)

Product code

OLO
21 CFR 882.4560

Predicate devices

2
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K233228
Device name
Spine Navigation and Robotic-Assistance Device
Company
Ecential Robotics
Country / Region
France(FR)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-09-28
Decision date
2024-06-14
Submission type
Traditional
Technology type
Robotic Navigation(AI inferred)
Clinical applications
Spine SurgeryRobotic AssistanceNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Subject Device and its predicates are indicated:
- for open or percutaneous spinal procedures.
- for a use based on the identification of the bony structure of the spine.
- to be used by surgeons.
- for the placement of spinal implants.

Intended Use

The Subject Device and its predicates are indicated: - for open or percutaneous spinal procedures. - for a use based on the identification of the bony structure of the spine. - to be used by surgeons. - for the placement of spinal implants.

Device Description

The Subject Device and its predicates are intended: - to position and orientate surgical instruments - to be used in Freehand Navigation Guidance Mode and Robotic-Assisted Guidance mode. The Subject Device and its predicates are substantially equivalent in terms of: - General technology description. - Principles of operation of the Robotic-Assisted Guidance Mode. - Principles of operation of the Freehand Navigation Mode. - Operation Principles (SURGIVISIO Device allows to navigate targeting needles.) - Surgical workflow in Freehand Navigation. - Surgical workflow in Robotic-Assisted Guidance. - DICOM compatibility. - User's Control. - Graphical User Interface.

Summary parsed at:2026-06-19 05:28:03 UTC

Predicate devices

2

K233228 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K233228 as a predicate