FDA.reportPublic FDA data

ARVIS ®

Primary DI
00810180351003
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
2.5.1
Catalog number
IN-18100
Device description
ARVIS Screencast App Android
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K243980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243980000ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited2025-03-21SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810180351003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810180351003008101803510038101803510030810180351003

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation system application softwareAn individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757918953
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810180351720360CAS3.2.0AN-123402026-07-09
00810180350020ARVIS ®IN-280002025-11-17
00810180350037ARVIS ®IN-280102025-11-17
00810180350044ARVIS ®IN-280202025-11-17
00810180350051ARVIS ®IN-280502025-11-17
00810180350068ARVIS ®IN-280702025-11-17
00810180350099ARVIS ®IN-281002025-11-17
00810180350105ARVIS ®IN-281202025-11-17
00810180350112ARVIS ®IN-281302025-11-17
00810180350167ARVIS ®IN-281502025-11-17
00810180350174ARVIS ®IN-281602025-11-17
00810180350785ARVIS ®IN-290002025-11-17
00810180350792ARVIS ®IN-291002025-11-17
00810180350808ARVIS ®IN-290022025-11-17
00810180350815ARVIS ®IN-290052025-11-17
00810180350822ARVIS ®IN-290032025-11-17
00810180350839ARVIS ®IN-290072025-11-17
00810180350846ARVIS ®IN-290082025-11-17
00810180350853ARVIS ®IN-290182025-11-17
00810180350860ARVIS ®IN-290302025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00193982621940DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622039DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622091DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622114DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622138DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995218Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995232Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14