FDA.reportPublic FDA data

Op.n Core

Primary DI
03701311501435
Brand
Op.n Core
Company
ECENTIAL ROBOTICS
Model
I01014
Published
2025-03-20
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
03701311501435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311501435037013115014353701311501435

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system workstation, mobileA mains electricity (AC-powered) component of an optical surgical navigation device tracking system intended to act as the user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a mobile (on wheels) computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software; it may be a stand-alone unit or integrated into an endoscopic video tower or surgical pendant. The system provides an optical tool for the tracking of instruments and patient with respect to pre-acquired images (e.g., CT or MRI scan), or real-time image data [e.g., ultrasound (US) data].

Sterilization Methods#

Method table
Method

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
037013115004453DSRW SoftwareL000162023-03-01
03701311500995Broach Set SPX1A010212023-09-04
037013115009713D Offset Imaging Set SPX1A010382023-09-04
03701311501015Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mmA010202023-09-04
03701311501039Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mmA010282023-09-04
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
03701311500322CoBotI000192023-03-01
03701311500407SURGIVISIOI000012023-03-01
03701311501442Op.n Core Power CordI010152025-11-04
03701311501459Op.n Core ethernet cableI010162025-11-04
03701311501466Op.n Core HDMI cableI010182025-11-04
03701311500032Broach Set SPX1A000212023-03-01
03701311501497Op.n ChoiceSpine AppL600182025-05-15
037013115000183D Imaging Set SPX1A000182023-03-01
037013115003913D Offset Imaging Set SPX1A000382023-03-01
03701311501275Op.n CameraI000262025-03-20
03701311500865Op.n Tracker AA000632025-03-20
03701311500872Op.n Tracker BA000642025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150057078AXIS AP ROBOTIC TOOL CHANGER 9736681MEDTRONIC NAVIGATION, INC.OLO2026-08-09
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150067626KIT 9736691 SPINE REFERENCINGMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOLO2026-08-03
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30