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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (10) RASP (HTR) (8) EXTRACTOR (HWB) (1)

Premarket Exempt

Yes No

Clear

ENDOSKELETON® TA - 00191375000433 Catalog Number :

Device Description : Theaded Holder

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000440 Catalog Number :

Device Description : Extractor Tool

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HWB, LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000457 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 8mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR, LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000464 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 9mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : LXH, HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000471 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 10mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR, LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000488 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 11mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR, LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000495 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 12mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : LXH, HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000501 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 13mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : LXH, HTR

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000518 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 14mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : HTR, LXH

Prescription Use : Yes

Device Count : 1

ENDOSKELETON® TA - 00191375000525 Catalog Number :

Device Description : 7 Deg Lordotic, Rasp, Standard, 15mm

Device Class : 1

Duns Number: 830350380

Premarket Exempt : No

Product Code : LXH, HTR

Prescription Use : Yes

Device Count : 1

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