MEDTRONIC NAVIGATION, INC.

Address:826 COAL CREEK CIR.,LOUISVILLE,CO,80027,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

Neurological stereotaxic Instrument (HAW) (9) Orthopedic stereotaxic instrument (OLO) (1)

Premarket Exempt

No Yes

Clear

N/A - 00885074366661 Catalog Number :

Device Description : CART 9731844 POLESTAR VIEW STATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

N/A - 00885074366715 Catalog Number :

Device Description : VIEW STATION 9731839 ASSEMBLED

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074366722 Catalog Number :

Device Description : HARDWARE 9731838 POLESTAR INTEGRATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074368825 Catalog Number :

Device Description : CART 9731873 POLESTAR NAVIGATION ASSY

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074368856 Catalog Number :

Device Description : RACK 9731883 POLESTAR ASSY INT'L

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

PoleStar® - 00885074370064 Catalog Number :

Device Description : POLESTAR, 9731357, PASSIVE PLANAR-BRONZE

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

AxiEM™ - 00885074403748 Catalog Number :

Device Description : SW 9732243 CRANIAL APPLICATION INAV

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074403755 Catalog Number :

Device Description : SW 9732244 3D SPINE APPLICATION INAV

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074416922 Catalog Number :

Device Description : PROBE 9732296 LONG POINTER 2.5 BALL

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074435558 Catalog Number :

Device Description : INSTALL DVD 9731958 SPINE TOOLSA^

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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