MEDTRONIC SOFAMOR DANEK, INC.

Address:4340 Swinnea Road,Memphis,TN,38118,US

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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) (3) Orthopedic manual surgical instrument (LXH) (3) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (2) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE (MQP) (2) Orthosis, spondylolisthesis spinal fixation (MNH) (2) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

Medtronic Reusable Instrument - 20673978069146 Catalog Number :

Device Description : DISTRACTOR 875-087 PINS STER 12MM

Device Class : 1

Duns Number: 830350380

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 10

Medtronic Reusable Instrument - 20673978069153 Catalog Number :

Device Description : INSTRUMENT 875-088 14MM DSTRCT PIN STRL

Device Class : 1

Duns Number: 830350380

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 10

Medtronic Reusable Instrument - 20673978069160 Catalog Number :

Device Description : DISTRACTOR 875-089 PINS 16MM

Device Class : 1

Duns Number: 830350380

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 10

CD HORIZON® Spinal System - 20673978074027 Catalog Number :

Device Description : SCREW 89104 CD THR PLUG

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP

Prescription Use : Yes

Device Count : 3

PYRAMESH® C Titanium Mesh - 20673978081148 Catalog Number :

Device Description : MESH 905-800 PYRM END RING SET SCRW

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 25

CD HORIZON® Spinal System - 20673978111401 Catalog Number :

Device Description : SCREW C806 CCD CL IMPL 6MM PLUGS

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 3

CD HORIZON® Spinal System - 20673978111425 Catalog Number :

Device Description : SCREW C806T CCD CL IMPL 6MM PLUGS TI

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP

Prescription Use : Yes

Device Count : 3

MSD WIRE System - 20681490717254 Catalog Number :

Device Description : WIRE 3510 DBL SIDED SS DIA 10/10 PK

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 10

N/A - 20721902034132 Catalog Number :

Device Description : PLIERS 836-062 REDUCTION PLIERS LOCKSCRW

Device Class :

Duns Number: 830350380

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 2

VERTE-SPAN® Spinal System - 20721902068342 Catalog Number :

Device Description : M4 BREAK-OFF SCREW

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, MQP

Prescription Use : Yes

Device Count : 2

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