SpineArt SA

Address:Chemin du Pre-Fleuri 3,Plan-les-Ouates Geneve,CH

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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) Screwdriver (HXX) (1)

Premarket Exempt

Yes No

Clear

PERLA TL MIS NAV-Instruments - 07640450868787 Catalog Number : NAV-IN 36 80-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø8.0 (Ø8.5 SCREW)

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868794 Catalog Number : NAV-IN 36 85-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø8.5

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868800 Catalog Number : NAV-IN 36 90-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø9.0 (Ø9.5 SCREW)

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868817 Catalog Number : NAV-IN 36 95-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø9.5

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868824 Catalog Number : NAV-IN 36 10-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø10.0 (Ø10.5 SCREW)

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868831 Catalog Number : NAV-IN 36 15-N

Device Description : PERLA TL NAV. CANNULATED TAP Ø10.5

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868848 Catalog Number : NAV-IN 37 10-N

Device Description : PERLA TL NAV. SCREWDRIVER XTAB

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868855 Catalog Number : NAV-IN 37 20-N

Device Description : PERLA TL NAV LOCKING SCREWDRIVER XTAB

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA TL MIS NAV-Instruments - 07640450868886 Catalog Number : NAV-IN 35 10-N

Device Description : PERLA TL NAV. CORTICAL SCREWDRIVER TUBE

Device Class : 2

Duns Number: 483016148

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

PERLA ® TL - 07640450868923 Catalog Number : TLF-IN 23 10-N

Device Description : LOCKING SCREWDRIVER TUBE

Device Class : 1

Duns Number: 483016148

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

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