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

Clear

REMI Robotic Navigation System - 00850026574234 Catalog Number :

Device Description : Driver

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574241 Catalog Number :

Device Description : Reference Arm

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574258 Catalog Number :

Device Description : 8mm Hex Driver, Reference Arm

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574333 Catalog Number :

Device Description : Camera Assembly

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574340 Catalog Number :

Device Description : Fusion Robotics Surgical Guidance System

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574357 Catalog Number :

Device Description : Camera Yoke

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574364 Catalog Number :

Device Description : Spine System Software

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574500 Catalog Number : 1061

Device Description : MIS Driver

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574555 Catalog Number :

Device Description : 150mm x 6mm PSIS Pin

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

REMI Robotic Navigation System - 00850026574579 Catalog Number :

Device Description : 100mm x 6mm PSIS Pin

Device Class : 2

Duns Number: 117229400

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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