FDA.reportPublic FDA data

CoBot

Primary DI
03701311500322
Brand
CoBot
Company
ECENTIAL ROBOTICS
Model
I00019
Published
2023-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221028000
K231886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221028000SURGIVISIO DeviceEcential Robotics2022-07-06OLO
K231886000SURGIVISIO DeviceEcential Robotics2023-07-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701311500322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311500322037013115003223701311500322

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical systemAn assembly of electromechanical devices typically used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of, e.g., an operator console and arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33458005520service@ecential-robotics.com

Regulatory Flags#

DUNS number
261610964
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701311500865Op.n Tracker AA000632025-03-20
03701311500872Op.n Tracker BA000642025-03-20
03701311500889Op.n Tracker CA000652025-03-20
03701311500896Op.n Tracker DA000662025-03-20
03701311501275Op.n CameraI000262025-03-20
03701311501282Tracker fixation screwA000752025-03-20
03701311501435Op.n CoreI010142025-03-20
03701311501374Patient Tracker SPX1A010392023-12-15
037013115009403D Imaging Set SPX1A010182023-09-06
03701311500742Fixation screwA400472023-09-04
03701311500759CoBot, Tool HolderA400442023-09-04
03701311500773Robotic, Tool Holder – TrackerA400592023-09-04
037013115009713D Offset Imaging Set SPX1A010382023-09-04
03701311501053Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mmA010192023-09-04
03701311501077Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mmA010292023-09-04
03701311501121SURGIVISIO DEVICEI010012023-09-04
03701311500285Robotic, Tool Holder - Fixation ScrewA400072023-03-02
037013115000183D Imaging Set SPX1A000182023-03-01
03701311500070Navigation Set SPX1, Targeting Needle Bevel Tip - 11G, 125mmA000192023-03-01
03701311500230Robotic, Tool Holder Dia. 6 mmA400042023-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
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07613327460797Navigation EnabledStryker CorporationOLO2019-10-16
07613327460810Navigation EnabledStryker CorporationOLO2019-10-16
07613327460827Navigation EnabledStryker CorporationOLO2019-10-16
07613327460834Navigation EnabledStryker CorporationOLO2019-10-16
07613327460841Navigation EnabledStryker CorporationOLO2019-10-16
07613327460858Navigation EnabledStryker CorporationOLO2019-10-16
07613327460865Navigation EnabledStryker CorporationOLO2019-10-16
07613327460872Navigation EnabledStryker CorporationOLO2019-10-16
07613327460889Navigation EnabledStryker CorporationOLO2019-10-16
07613327460896Navigation EnabledStryker CorporationOLO2019-10-16