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) (4) Wire, surgical (LRN) (3) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (HWE) (1) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (1) Orthopedic stereotaxic instrument (OLO) (1) Orthosis, spondylolisthesis spinal fixation (MNH) (1) Thoracolumbosacral pedicle screw system (NKB) (1) Appliance, fixation, spinal intervertebral body (KWQ) (1)

Premarket Exempt

No Yes

Clear

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169588022 Catalog Number :

Device Description : SCREW G73733032513 4.5X13 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169588039 Catalog Number :

Device Description : SCREW G73733032515 4.5X15 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169588046 Catalog Number :

Device Description : SCREW G73733032517 4.5X17 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

CD HORIZON® SOLERA® Spinal System - 20643169885831 Catalog Number :

Device Description : SET SCREW PACK 6534530 4 PACK SET SCREW

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : NKB, OLO, KWQ, KWP, HWE

Prescription Use : Yes

Device Count : 4

CD HORIZON® Spinal System - 20673978007643 Catalog Number :

Device Description : SCREW 110300 BABY CD SELF BRKNG

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, MNH, KWP, MNI

Prescription Use : Yes

Device Count : 4

MSD WIRE System - 20673978017758 Catalog Number :

Device Description : WIRE 3508 DBL SIDED SS DIA 08/10 PK

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 10

MSD WIRE System - 20673978017826 Catalog Number :

Device Description : WIRE PEARL-TIP 3512 1.2MMX37.5CM

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 10

ATLAS® Cable System - 20673978047885 Catalog Number :

Device Description : CABLE 826-012 DBL CBL WINTGL CRMPSS

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : LRN

Prescription Use : No

Device Count : 12

ATLAS® Cable System - 20673978047977 Catalog Number :

Device Description : CABLE 826-212 DBL CBL WINTGRL CRMP TI

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : LRN

Prescription Use : No

Device Count : 12

ATLAS® Cable System - 20673978048004 Catalog Number :

Device Description : WASHER 826-217 FLAT BAR TI

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : LRN

Prescription Use : No

Device Count : 2

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