FDA.reportPublic FDA data

Op.n Core ethernet cable

Primary DI
03701311501459
Brand
Op.n Core ethernet cable
Company
ECENTIAL ROBOTICS
Model
I01016
Published
2025-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K242914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242914000Op.n(TM) NavigationEcential Robotics2025-03-07OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701311501459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311501459037013115014593701311501459

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Regulatory Flags#

DUNS number
261610964
Device count
1
Lot or batch
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
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
04056481146429Automatic RegsitrationBrainlab SEOLO2026-02-20
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350099ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350112ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481146320Alignment Software SpineBrainlab SEOLO2025-06-16
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350433ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350556ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350693ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00850030914347SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850030914354SkyWalkerMicroport Navibot International LLCOLO2025-04-24
05056139245374Apollo KneeCORIN LTDOLO2025-04-07
05056139250644Apollo KneeCORIN LTDOLO2025-04-07
00850042604014ParadigmProprio, Inc.OLO2025-03-21
00850042604168ParadigmProprio, Inc.OLO2025-03-21
00850042604175ParadigmProprio, Inc.OLO2025-03-21