Neo Medical SA

Address:Route de Lausanne 157A,Villette (Lavaux) Vaud,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

Thoracolumbosacral Pedicle Screw System (NKB) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Neo Medical Pedicle screw kit - 07640177820327 Catalog Number : RD-00-90-ST

Device Description : Rod kit straight 90 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820334 Catalog Number : RD-01-00-ST

Device Description : Rod kit straight 100 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820341 Catalog Number : RD-01-30-ST

Device Description : Rod kit straight 130 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820358 Catalog Number : RD-01-60-ST

Device Description : Rod kit straight 160 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820365 Catalog Number : RD-02-00-ST

Device Description : Rod kit straight 200 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820372 Catalog Number : RD-03-00-ST

Device Description : Rod kit straight 300 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle screw kit - 07640177820501 Catalog Number :

Device Description : Universal T-Handle

Device Class : 1

Duns Number: 486778843

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw Kit - 07640177820518 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø4.5 x 25mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820525 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø4.5 x 30mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820532 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø4.5 x 35mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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