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 - 00810055520107 Catalog Number :

Device Description : 10.0mm x 70mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520114 Catalog Number :

Device Description : 10.0mm x 75mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520121 Catalog Number :

Device Description : 10.0mm x 80mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520138 Catalog Number :

Device Description : 10.0mm x 85mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520145 Catalog Number :

Device Description : 10.0mm x 90mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520152 Catalog Number :

Device Description : 10.0 mm x 40 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 - 00810055520169 Catalog Number :

Device Description : 10.0 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 - 00810055520176 Catalog Number :

Device Description : 10.0 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 - 00810055520183 Catalog Number :

Device Description : 10.0 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 - 00810055520190 Catalog Number :

Device Description : 10.0 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

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