ORTHOKEY ITALIA SRL

ORTHOKEY ITALIA SRL

Address:Piazza Puccini 26,Firenze,IT

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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

Perseus - 08052675960013 Catalog Number : 20100801

Device Description : Perseus Device Sensor

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Perseus - 08052675960020 Catalog Number : 20902401

Device Description : Extramedullary Jig

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960037 Catalog Number : 20902501

Device Description : Femur Cutting Guide 1.3 mm

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960044 Catalog Number : 20902503

Device Description : Perseus Tibial Cutting Guide L - 1.3 mm

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960051 Catalog Number : 20902504

Device Description : Perseus Tibial Cutting Guide R - 1.3 mm

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960068 Catalog Number : 20902609

Device Description : Femoral Spacer 9 mm

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960082 Catalog Number : 20902801

Device Description : Pin Extractor

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960099 Catalog Number : 20902901

Device Description : Jacobs Adaptor

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960105 Catalog Number : 20903002

Device Description : Non Invasive Sensor Support (includes Silicon Strip, code 1165)

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

Perseus - 08052675960112 Catalog Number : 20904601

Device Description : Box Sterilizzation

Device Class : 2

Duns Number: 433594191

Premarket Exempt : No

Product Code : OLO

Prescription Use : No

Device Count : 1

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