FDA.reportPublic FDA data

ARVIS ®

Primary DI
00850012315506
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
16400
Device description
Tracker A
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
00850012315506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012315506008500123155068500123155060850012315506

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system spatial register, reusableA component of an optical surgical navigation device tracking system intended to localize/track the position/movement of a patient, fiducial marker and/or an optically navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or register surgical instrument size (e.g., length, width), in association with a computer assisted surgery (CAS). It may be attached to the patient, fiducial marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera [e.g., infrared (IR) light camera]; it is typically made of metal. This is a reusable device.

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
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

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Primary DI, Brand, Company table
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