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-iFuse-TORQ Instrument Set - 00810055520008 Catalog Number :

Device Description : iFuse-TORQ Instrument Set

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System-iFuse-TORQ Instrument Set, Revision - 00810055520015 Catalog Number :

Device Description : iFuse-TORQ Instrument Set, Revision

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520022 Catalog Number :

Device Description : 10.0mm x 30mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520039 Catalog Number :

Device Description : 10.0mm x 35mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520046 Catalog Number :

Device Description : 10.0mm x 40mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520053 Catalog Number :

Device Description : 10.0mm x 45mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520060 Catalog Number :

Device Description : 10.0mm x 50mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520077 Catalog Number :

Device Description : 10.0mm x 55mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520084 Catalog Number :

Device Description : 10.0mm x 60mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

iFuse TORQ Implant System - 00810055520091 Catalog Number :

Device Description : 10.0mm x 65mm iFuse-TORQ

Device Class : 2

Duns Number: 830127168

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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