FDA.reportPublic FDA data

ARVIS ®

Primary DI
00850012315483
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
16700
Device description
Tibial Reference Mount, Right
Published
2022-02-16
Public version status
Update
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
K203115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203115000ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.2021-07-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012315483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012315483008500123154838500123154830850012315483

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
757918953
Device count
1
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
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07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16
07613327460797Navigation EnabledStryker CorporationOLO2019-10-16
07613327460810Navigation EnabledStryker CorporationOLO2019-10-16
07613327460827Navigation EnabledStryker CorporationOLO2019-10-16
07613327460834Navigation EnabledStryker CorporationOLO2019-10-16
07613327460841Navigation EnabledStryker CorporationOLO2019-10-16
07613327460858Navigation EnabledStryker CorporationOLO2019-10-16
07613327460865Navigation EnabledStryker CorporationOLO2019-10-16
07613327460872Navigation EnabledStryker CorporationOLO2019-10-16
07613327460889Navigation EnabledStryker CorporationOLO2019-10-16
07613327460896Navigation EnabledStryker CorporationOLO2019-10-16