Paradigm Spine GmbH

Paradigm Spine GmbH

Address:Eisenbahnstrabe 84,Wurmlingen Baden-Wurttemberg,DE

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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

Appliance, Fixation, Spinal Interlaminal (KWP) (6) Prosthesis, Spinous Process Spacer/Plate (NQO) (4)

Premarket Exempt

No Yes

Clear

coflex Bending pliers - 04260148890116 Catalog Number :

Device Class : 3

Duns Number: 537619731

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

coflex Crimping pliers - 04260148890123 Catalog Number :

Device Class : 3

Duns Number: 537619731

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

coflex Mallet - 04260148890130 Catalog Number :

Device Class : 3

Duns Number: 537619731

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

coflex Mallet cap - 04260148890147 Catalog Number :

Device Class : 3

Duns Number: 537619731

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

coflex-F trial, 8mm - 04260148890277 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

coflex-F trial, 10mm - 04260148890284 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

coflex-F trial, 12mm - 04260148890291 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

coflex-F trial, 14mm - 04260148890307 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

coflex-F trial, 16mm - 04260148890314 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

coflex-F™ Sterilization tray - 04260148890321 Catalog Number :

Device Class : 2

Duns Number: 537619731

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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