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 Pedicle Screw System - 07640177820549 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø4.5 x 40mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820556 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø4.5 x 45mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820563 Catalog Number :

Device Description : Rod kit straight 400 mm (2x)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Medical Pedicle Screw System - 07640177820679 Catalog Number :

Device Description : Pedicle marker inserter

Device Class : 1

Duns Number: 486778843

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820686 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø8.0 x 45mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820693 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø8.0 x 50mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820709 Catalog Number :

Device Description : Pedicle screw kit 2x(Ø8.0 x 55mm)

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820716 Catalog Number :

Device Description : Iliac screw Ø8.0 x 70mm

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820723 Catalog Number :

Device Description : Iliac screw Ø8.0 x 80mm

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Neo Pedicle Screw System - 07640177820730 Catalog Number :

Device Description : Iliac screw Ø8.0 x 90mm

Device Class : 2

Duns Number: 486778843

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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