MEDTECH

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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) (9) Neurological Stereotaxic Instrument (HAW) (2)

Premarket Exempt

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ROBOT STAND REFERENCE - 03760244030351 Catalog Number : ROSAS00134

Device Description : ROBOT STAND REFERENCEinstrument Rosa one (spine application)Navigation reference ROBOT STAND REFERENCEinstrument Rosa one (spine application)Navigation reference to monitor robot & camera stands relative motions

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

ROSA PLANNING STATION - 03760244030375 Catalog Number : ROSAS00369

Device Description : ROSA PLANNING STATIONLaptop computer with the following minimal configuration : ROSA PLANNING STATIONLaptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SHORT SPINE ADP - SST - 03760244030382 Catalog Number : ROSAS00112

Device Description : Short Spine Instrument Adaptorinstrument Rosa one 3.1 (spine application)Adaptor Short Spine Instrument Adaptorinstrument Rosa one 3.1 (spine application)Adaptor for 6MM cannula"

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

CANNULA Ø2.49/1.61MM L250MM - 03760244030412 Catalog Number : ROSAS00119

Device Description : Cannula Ø2.49/Ø1.60mm L250mminstrument Rosa one (spine application)Reducing tube Cannula Ø2.49/Ø1.60mm L250mminstrument Rosa one (spine application)Reducing tube for implantation of guidewires

Device Class :

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 2

STERILE ROBOT ARM INTERFACE - 03760244030436 Catalog Number : ROSAS00126

Device Description : Robot Arm Interfaceinstrument Rosa 3.0instrument ROSA One spine app 3.1

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW, OLO

Prescription Use : Yes

Device Count : 1

3D X-RAY PATTERN - 03760244030443 Catalog Number : ROSAS00128

Device Description : 3D X-RAY PATTERNinstrument Rosa one (spine application)Calibrated device to regi 3D X-RAY PATTERNinstrument Rosa one (spine application)Calibrated device to register intraoperative 3D exams

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

SHARP NAVIGATION PROBE - 03760244030474 Catalog Number : ROSAS00132

Device Description : Sharp navigation probeinstrument Rosa one (spine application)Straight navigation Sharp navigation probeinstrument Rosa one (spine application)Straight navigation probe, sharp

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

CANNULA Ø2.3MM L250MM - 03760244030528 Catalog Number : ROSAS00144

Device Description : Cannula Ø2.30mm/Ø1.80mm L250mminstrument Rosa one 3.1 (spine application)Reducin Cannula Ø2.30mm/Ø1.80mm L250mminstrument Rosa one 3.1 (spine application)Reducing tube for implantation of guidewires

Device Class :

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 2

SPINE INSTRUMENT HOLDER - 03760244030542 Catalog Number : ROSAS00146

Device Description : Spine Instrument Holderinstrument Rosa one (spine application)Instrument holder Spine Instrument Holderinstrument Rosa one (spine application)Instrument holder for neurosurgical instruments

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PIN CAP - 03760244030573 Catalog Number : ROSAS00151

Device Description : PIN CAPinstrument Rosa one (spine application)Cap to hammer percutaneous pin in PIN CAPinstrument Rosa one (spine application)Cap to hammer percutaneous pin in the iliac crest

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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