Insight Medical Systems, Inc.

Address:8601 Ranch Road 2222,Austin,TX,78730,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Stereotaxic Instrument (OLO) (10)

Premarket Exempt

Clear

ARVIS ® - 00850012315407 Catalog Number :

Device Description : Femoral Slot Adapter

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315414 Catalog Number :

Device Description : Tibial Slot Adapter

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315421 Catalog Number :

Device Description : Pin, 4mm x 115mm

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315438 Catalog Number :

Device Description : Femoral Reference Mount, Left

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315445 Catalog Number :

Device Description : Femoral Reference Mount, Right

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315452 Catalog Number :

Device Description : Femoral Cutting Block

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315469 Catalog Number :

Device Description : Adjustable Distal Guide

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315476 Catalog Number :

Device Description : Tibial Reference Mount, Left

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315483 Catalog Number :

Device Description : Tibial Reference Mount, Right

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315490 Catalog Number :

Device Description : Impactor Adapter, DJO

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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