ZIMMER SPINE, INC.

Address:CITE MONDIALE,BORDEAUX Nouvelle-Aquitaine,FR

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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) (4) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (4) Orthosis, spinal pedicle fixation, for degenerative disc disease (NKB) (4) Orthosis, spondylolisthesis spinal fixation (MNH) (4) Pedicle screw spinal system, adolescent idiopathic scoliosis (OSH) (4) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (4) Thoracolumbosacral Pedicle Screw System (NKB) (3) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (2) SCREWDRIVER (HXX) (1)

Premarket Exempt

No Yes

Clear

Pathfinder NXT - 00880304989405 Catalog Number : 07.00777.702

Device Description : PathFinder NXT® PAT Tap, 5.0mm

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : NKB

Prescription Use : No

Device Count : 1

Pathfinder NXT - 00880304989412 Catalog Number : 07.00777.703

Device Description : PathFinder NXT® PAT Tap, 6.0mm

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : NKB

Prescription Use : No

Device Count : 1

Pathfinder NXT - 00880304989436 Catalog Number : 07.00777.704

Device Description : PathFinder NXT® PAT Tap, 7.0mm

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : NKB

Prescription Use : No

Device Count : 1

Vitality® - 00889024009790 Catalog Number : 07.02053.001

Device Class : 1

Duns Number: 787663400

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009806 Catalog Number : 07.02054.001

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : KWP, MNH, KWQ, OSH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009813 Catalog Number : 07.02055.001

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : NKB, KWP, OSH, MNH, KWQ, MNI

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009844 Catalog Number : 07.02058.001

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : MNH, KWP, MNI, OSH, KWQ, NKB

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009851 Catalog Number : 07.02060.001

Device Class : 1

Duns Number: 787663400

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009868 Catalog Number : 07.02061.001

Device Class : 2

Duns Number: 787663400

Premarket Exempt : No

Product Code : NKB, KWQ, OSH, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

Vitality® - 00889024009875 Catalog Number : 07.02063.001

Device Class : 1

Duns Number: 787663400

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

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