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 ® - 00850012315308 Catalog Number :

Device Description : ARVIS Surgical Navigation System

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315315 Catalog Number :

Device Description : ARVIS Hip and Knee Instrument Set, Packaged

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315322 Catalog Number :

Device Description : Distal Guide Tracker

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315339 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 ® - 00850012315346 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 ® - 00850012315353 Catalog Number :

Device Description : Adapter, DJO Impactor

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315360 Catalog Number :

Device Description : Landmark Punch

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315377 Catalog Number :

Device Description : Charger, 25W USB-C, USA

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315384 Catalog Number :

Device Description : Femoral Slot Adapter, Parallel

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ARVIS ® - 00850012315391 Catalog Number :

Device Description : Tracker C

Device Class : 2

Duns Number: 080536842

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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