MEDTRONIC SOFAMOR DANEK, INC.

Address:1800 PYRAMID PLACE,Memphis,TN,38132,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

RASP (HTR) (4) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE (MQP) (4) TEMPLATE (HWT) (2)

Premarket Exempt

No Yes

Clear

ENDOSKELETON® TA VBR - 00191375000006 Catalog Number :

Device Description : Interbody Fusion Device 7 Degree Standard 18mm

Device Class : 2

Duns Number: 830350380

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000013 Catalog Number :

Device Description : Interbody Fusion Device 7 Degree Standard 20mm

Device Class : 2

Duns Number: 830350380

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000020 Catalog Number :

Device Description : Interbody Fusion Device 7 Degree Large 18mm

Device Class : 2

Duns Number: 830350380

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000037 Catalog Number :

Device Description : Interbody Fusion Device 7 Degree Large 20mm

Device Class : 2

Duns Number: 830350380

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000068 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 18mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000075 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 20mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000082 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Large, 18mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000099 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Large, 20mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000105 Catalog Number :

Device Description : Trial, 7 Deg Lordotic, Standard, 18mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA VBR - 00191375000112 Catalog Number :

Device Description : Trial, 7 Deg Lordotic, Standard, 20mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

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