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 - 00810055520206 Catalog Number :

Device Description : 10.0 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 - 00810055520213 Catalog Number :

Device Description : 10.0 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 - 00810055520220 Catalog Number :

Device Description : 10.0 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 - 00810055520237 Catalog Number :

Device Description : 10.0 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 - 00810055520244 Catalog Number :

Device Description : 10.0 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 - 00810055520251 Catalog Number :

Device Description : 10.0 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

iFuse TORQ Implant System - 00810055520268 Catalog Number :

Device Description : 11.5 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 - 00810055520275 Catalog Number :

Device Description : 11.5 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 - 00810055520282 Catalog Number :

Device Description : 11.5 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 - 00810055520299 Catalog Number :

Device Description : 11.5 mm x 45 mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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