FDA.reportPublic FDA data

ARVIS ®

Primary DI
09309001071011
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
IN-27300
Device description
ARVIS Surgical Planning Software
Published
2025-04-01
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
K240062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240062000ARVIS® ShoulderInsight Medical Systems, Inc.2024-04-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09309001071011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09309001071011093090010710119309001071011

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757918953
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810180350051ARVIS ®IN-280502025-11-17
00810180350099ARVIS ®IN-281002025-11-17
00810180350112ARVIS ®IN-281302025-11-17
00810180350013ARVIS ®IN-226002025-07-29
00810180350266ARVIS ®IN-240002025-05-23
00810180350433ARVIS ®IN-186002025-05-23
00810180350525ARVIS ®IN-164002025-05-23
00810180350556ARVIS ®IN-104002025-05-23
00810180350563ARVIS ®IN-161002025-05-23
00810180350693ARVIS ®IN-106002025-05-23
00810180350280ARVIS ®IN-221002025-03-18
00850012315865ARVIS ®240002024-06-17
00850012315889ARVIS ®221002024-06-17
00850012315650ARVIS ®186002023-09-28
00850012315391ARVIS ®161002022-02-16
00850012315506ARVIS ®164002022-02-16
00850012315513ARVIS ®165002022-02-16
00850012315056ARVIS ®101002021-11-12
00850012315070ARVIS ®103002021-11-12
00850012315087ARVIS ®104002021-11-12

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