Fusion Robotics, LLC

Fusion Robotics, LLC

Address:168 Centennial Parkway,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

Orthopedic Stereotaxic Instrument (OLO) (10)

Premarket Exempt

No

Clear

REMI Robotic Navigation System - 00850026574135 Catalog Number :

Device Description : Registration Array

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574142 Catalog Number :

Device Description : Guide Tube with Tracker

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574159 Catalog Number :

Device Description : 8mm Guide Sleeve

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574166 Catalog Number :

Device Description : Awl

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574173 Catalog Number :

Device Description : Awl Tap Cap

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574180 Catalog Number :

Device Description : Instrument Tracker

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574197 Catalog Number :

Device Description : Slap Hammer

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574203 Catalog Number :

Device Description : 4.5mm Tap

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574210 Catalog Number :

Device Description : 5.5mm Tap

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574227 Catalog Number :

Device Description : 6.5mm Tap

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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