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

Neurological Stereotaxic Instrument (HAW) (5) Orthopedic Stereotaxic Instrument (OLO) (5)

Premarket Exempt

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MEDTRONIC FHC MICRODRIVE HOLDER - 03760244030108 Catalog Number : ROSAS00018

Device Description : MEDTRONIC FHC MICRODRIVE HOLDER (V2)instrument Rosa 3.0mechanical holder for FHC

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

MEDTRONIC FHC MICRODRIVE HOLDER - 03760244030115 Catalog Number : ROSAS00019

Device Description : MEDTRONIC FHC MICRODRIVE HOLDER (V3)instrument Rosa 3.0instrument Rosa 3.1mechan

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

RED Q-CONNECT NAV REF - 03760244030245 Catalog Number : ROSAS00165

Device Description : Red Nav ReferenceRed Nav Reference reference for Rosa One (Spine application)

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

YELLOW Q-CONNECT NAV REF - 03760244030252 Catalog Number : ROSAS00166

Device Description : Yellow Nav ReferenceYellow Nav Reference for Rosa One (Spine application)

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

BALL HEX ALLEN WRENCH 4MM - 03760244030269 Catalog Number : ROSAS00188

Device Description : ball hex allen wrench 4 mm for Rosa One - Application Spine rev-00

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

BALL HEX DRIVER 5MM - 03760244030283 Catalog Number : ROSAS00189

Device Description : ball hex driver 5 mm for Rosa One (Spine application) revision 00

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PEEK INSTRUMENT ADAPTOR Ø1.8MM - 03760244030290 Catalog Number : ROSAS00060

Device Description : PEEK INSTRUMENT ADAPTOR Ø1.8MMinstrument Rosa 3.0 instrument Rosa 3.1instrument

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SEEG SST DRILL ADAPTOR Ø2.5MM - 03760244030306 Catalog Number : ROSAS00080

Device Description : Seeg Drill Adaptor Ø2.50 mminstrument Rosa 3.0 instrument Rosa 3.1stainless stee

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SEEG SST CANNULA ADAPTOR Ø4.0MM - 03760244030313 Catalog Number : ROSAS00090

Device Description : SEEG Cannula Adaptor Ø4.00 mminstrument Rosa 3.0 instrument Rosa 3.1stainless st

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ROBOT ARM REFERENCE - 03760244030344 Catalog Number : ROSAS00133

Device Description : ROBOT ARM REFERENCEinstrument Rosa one (spine application)Navigation reference t

Device Class : 2

Duns Number: 264502977

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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