FDA.reportPublic FDA data

Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm

Primary DI
03701311501039
Brand
Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm
Company
ECENTIAL ROBOTICS
Model
A01028
Published
2023-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701311501039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311501039037013115010393701311501039

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
261610964
Device count
1
Lot or batch
true
Expiration 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
04056481147969Spine and Trauma NavigationBrainlab SEOLO2026-10-19
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
04056481144906Spine &Trauma NavigationBrainlab SEOLO2024-11-14
04056481146238PATIENT REFERENCE ARRAY SPINE & TRAUMABrainlab SEOLO2024-11-14
04056481146603ADAPTER SHORT FOR PATIENT REFERENCE CLAMPBrainlab SEOLO2024-11-14
04056481146610ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAYBrainlab SEOLO2024-11-14
04056481144753Drill Guide ArrayBrainlab SEOLO2024-06-04
04056481144760Drill Guide Depth Control (60 - 100 mm)Brainlab SEOLO2024-06-04
04056481144777Drill Guide Depth Control (0 - 60 mm)Brainlab SEOLO2024-06-04
04056481144784Drill Guide Tube (4.5 mm)Brainlab SEOLO2024-06-04
04056481144791Drill Guide Tube (3.2 mm)Brainlab SEOLO2024-06-04
04056481144807Drill Guide Tube (2.6 mm)Brainlab SEOLO2024-06-04
04056481144814Drill Guide Tube (2.4 mm)Brainlab SEOLO2024-06-04
04056481144821Drill Guide Tube (2.0 mm)Brainlab SEOLO2024-06-04
04056481144838Drill Guide HandleBrainlab SEOLO2024-06-04
04056481145057Drill Guide Trocar Insert (2.0 mm)Brainlab SEOLO2024-06-04
04056481145064Drill Guide Trocar Insert (2.4 mm)Brainlab SEOLO2024-06-04
04056481145071Drill Guide Trocar Insert (2.6 mm)Brainlab SEOLO2024-06-04