Si-Bone Inc.

Address:471 El Camino Real, Suite 101,Santa Clara,CA,95050,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 - 00810055520404 Catalog Number :

Device Description : 11.5 mm x 45 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520411 Catalog Number :

Device Description : 11.5 mm x 50 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520428 Catalog Number :

Device Description : 11.5 mm x 55 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520435 Catalog Number :

Device Description : 11.5 mm x 60 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520442 Catalog Number :

Device Description : 11.5 mm x 65 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520459 Catalog Number :

Device Description : 11.5 mm x 70 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520466 Catalog Number :

Device Description : 11.5 mm x 75 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520473 Catalog Number :

Device Description : 11.5 mm x 80 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520480 Catalog Number :

Device Description : 11.5 mm x 85 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520497 Catalog Number :

Device Description : 11.5 mm x 90 mm iFuse-TORQ, Lag

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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