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) Intervertebral fusion device with bone graft, lumbar (MAX) (1) Orthopedic stereotaxic instrument (OLO) (1)

Premarket Exempt

No Yes

Clear

N/A - 00613994151179 Catalog Number :

Device Description : FRAME, 9732353, PERC REF, CROSS PIN

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : MAX, OLO

Prescription Use : Yes

Device Count : 1

N/A - 00613994151223 Catalog Number :

Device Description : CAP, 9732562, TAP, CROSS PIN

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151230 Catalog Number :

Device Description : CANNULA 9732563 100MM

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151247 Catalog Number :

Device Description : SLAP HAMMER, 9732564, CROSS PIN

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151261 Catalog Number :

Device Description : DILATOR, 9732565, 100MM

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151278 Catalog Number :

Device Description : DILATOR, 9732771, 150MM

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151285 Catalog Number :

Device Description : CANNULA 9732772 150MM

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151308 Catalog Number :

Device Description : TRAY, 9732774, PERC REF

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994151315 Catalog Number :

Device Description : LID, 9732775, PERC REF

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994155344 Catalog Number :

Device Description : TRK KIT, 9732777, WRLESS, 12IN, 96-9800

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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