FDA.reportPublic FDA data

ARVIS ®

Primary DI
00810180350945
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
IN-23620
Device description
ARVIS GLOBAL SHOULDER 2.0 NAVIGATION SYSTEM
Published
2025-07-29
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
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810180350945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810180350945008101803509458101803509450810180350945

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757918953
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810180350877ARVIS ®IN-290012025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084604003OptiVu Shoulder Adapter HandleMR Surgical Solutions LLCSBF2026-06-03
00850084604010OptiVu Shoulder Pin InserterMR Surgical Solutions LLCSBF2026-06-03
00850084604027OptiVu Shoulder Cut GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604034OptiVu Shoulder StylusMR Surgical Solutions LLCSBF2026-06-03
00850084604041OptiVu Shoulder Reaming GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604058OptiVu Shoulder Clocking GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604089OptiVu Shoulder Sterile TrayMR Surgical Solutions LLCSBF2026-06-03
00850084604096OptiVu Shoulder Software ApplicationMR Surgical Solutions LLCSBF2026-06-03
00850084604102OptiVu Shoulder Humeral GaugeMR Surgical Solutions LLCSBF2026-06-03
00850084604119OptiVu Shoulder Tracker KitMR Surgical Solutions LLCSBF2026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCSBF2026-06-03
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
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