Si-Bone Inc.

Address:2380 Owen St.,Santa Clara,CA,95054,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

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

Clear

iFuse TORQ Implant System - 00810055520503 Catalog Number :

Device Description : 13.5 mm x 30 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520510 Catalog Number :

Device Description : 13.5 mm x 35 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520527 Catalog Number :

Device Description : 13.5 mm x 40 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520534 Catalog Number :

Device Description : 13.5 mm x 45 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520541 Catalog Number :

Device Description : 13.5 mm x 50 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520558 Catalog Number :

Device Description : 13.5 mm x 55 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520565 Catalog Number :

Device Description : 13.5 mm x 60 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520572 Catalog Number :

Device Description : 13.5 mm x 65 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520589 Catalog Number :

Device Description : 13.5 mm x 70 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520596 Catalog Number :

Device Description : 13.5 mm x 75 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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