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 ® - 00850012315100 Catalog Number :

Device Description : Tracker B

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315117 Catalog Number :

Device Description : 3.5mm Hex Driver

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315124 Catalog Number :

Device Description : 2.5mm Ball Driver

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315131 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 ® - 00850012315148 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 ® - 00850012315155 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 ® - 00850012315162 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 ® - 00850012315179 Catalog Number :

Device Description : Adjustable Cutting Block

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315186 Catalog Number :

Device Description : Distal Guide

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315193 Catalog Number :

Device Description : Tracker A

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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