Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021060474

FEI Number

3021060474

Entity Name

ECENTIAL ROBOTICS

City/State/Country

Gieres Isere, FR

Establishment Address

2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1, Gieres Isere 38610, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ecential Robotics (Owner Number: 10084446)

Owner / Operator Contact Address

2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1, Gieres, FR-38 38610, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242914

PMA Number

N/A

All Registered Proprietary Names

A40047 - Fixation Screw A40043 - 3.5 mm Hex Head Screwdriver A40046 - CoBot, Drill Guide - Sleeve A40041 - CoBot, Drill Bit A40059 - Robotic, Tool Holder - Tracker A40045 - CoBot, Spine Instruments Tray A40044 - CoBot, Tool Holder A40042 - CoBot, Drill Guide - Cortical Tip I00019 - CoBot A01039 - Patient Tracker SPX1 I01014 - Op.n Core A00075 - Tracker fixation screw A00066 - Op.n Tracker D I00026 - Op.n Camera A00067 - Navigation Instrument tray I01015 - Op.n Core Power Cord L60018 - Op.n ChoiceSpine App A00065 - Op.n Tracker C I01018 - Op.n Core HDMI cable L60017 - Op.n Perla TL Nav Software A00064 - Op.n Tracker B I01016 - Op.n Core ethernet cable A00063 - Op.n Tracker A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-08-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-11

Official Correspondent

Elodie bouillet

US Agent Details

Lisa Jacobs Email: lisa.jacobs@ecential-robotics.com Phone: (239) 3229839

Related Public Records

Same Entity

Ecential Robotics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021060474. Last updated year: 2026. Please use registration number 3021060474 when referencing this establishment in official correspondence.