FDA.reportPublic FDA data

ARTAS iX

Primary DI
00850470007524
Brand
ARTAS iX
Company
RESTORATION ROBOTICS, INC.
Model
System
Catalog number
FP-45000
Published
2018-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ONAComputer Assisted Hair Harvesting System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONAComputer Assisted Hair Harvesting SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173358000ARTAS SystemRestoration Robotics, Inc.2018-03-16ONA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850470007524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850470007524008504700075248504700075240850470007524

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

Regulatory Flags#

DUNS number
627212587
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90850470007008ARTAS System CartFP-400002016-08-15
00850470007012ARTAS System ChairASY-451792016-08-15
00850470007029ARTAS SystemAccessories KitFP-260002016-08-15
00850470007531ARTAS iXChairFP-470002018-11-12
00850470007562Disposable Kit, Sterile and Non Sterile, iX 18G 4 ProngFP-1027682018-11-12
00850470007579Disposable Kit, Sterile and Non Sterile, iX 19G 4 ProngFP-1027692018-11-12
00850470007623Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX18GFP-1027772018-11-12
00850470007630Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX19GFP-1027782018-11-12
00850470007364Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile18G 2 Prong2018-03-07
00850470007371Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile18G 4 Prong2018-03-07
00850470007388Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile19G 2 Prong2018-03-07
00850470007395Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile19G 4 Prong2018-03-07
00850470007401Disposable Kit, Sterile (S)18G 2 Prong2018-03-07
00850470007425Disposable Kit, Sterile (S)19G 2 Prong2018-03-07
00850470007432Disposable Kits, Sterile and Non-Sterile (S)19G 2 Prong2018-03-07
00850470007449Disposable Kit, Sterile (S)20G 2 Prong2018-03-07
00850470007456Disposable Kits, Sterile and Non-Sterile (S)20G 2 Prong2018-03-07
00850470007463Disposable Kit, Sterile (S)18G 4 Prong2018-03-07
00850470007470Disposable Kits, Sterile and Non-Sterile (S)18G 4 Prong2018-03-07
00850470007487Disposable Kit, Sterile (S)19G 4 Prong2018-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060830079ARTAS SystemVenus Concept Inc.ONA2023-06-08
00810060831632ARTAS iX Venus Concept Inc.ONA2018-11-12
00850470007531ARTAS iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007562Disposable Kit, Sterile and Non Sterile, iX RESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007579Disposable Kit, Sterile and Non Sterile, iX RESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007623Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007630Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iXRESTORATION ROBOTICS, INC.ONA2018-11-12
00850470007364Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007371Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007388Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007395Disposable Kit, Punch and Needle Assembly, 5 Pack SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007401Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007418Disposable Kits, Sterile and Non-SterileRESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007425Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007432Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007449Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007456Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007463Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007470Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007487Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007494Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007500Disposable Kit, Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007517Disposable Kits, Sterile and Non-Sterile (S)RESTORATION ROBOTICS, INC.ONA2018-03-07
00850470007289Disposable Kit, 20G SterileRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007296Disposable Kits, 20G RESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007302Disposable Kit, 20G SterileRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007319Disposable Kits, 20GRESTORATION ROBOTICS, INC.ONA2017-01-31
00850470007326Disposable KitRESTORATION ROBOTICS, INC.ONA2016-09-08
00850470007333Disposable KitRESTORATION ROBOTICS, INC.ONA2016-09-08
00850470007340Disposable KitsRESTORATION ROBOTICS, INC.ONA2016-09-08