ALEVIO, LLC

Address:200 Cahaba Park Circle,Birmingham,AL,35242,US

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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

SiCure Sacroiliac Joint Fusion System - B4369000950 Catalog Number : 900.095

Device Description : Load Distribution Cap, 9.5mm DIA.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095350 Catalog Number : 900.095.35

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 35mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095400 Catalog Number : 900.095.40

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 40mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095450 Catalog Number : 900.095.45

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 45mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095500 Catalog Number : 900.095.50

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 50mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095550 Catalog Number : 900.095.55

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 55mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900095600 Catalog Number : 900.095.60

Device Description : Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 60mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B436900110 Catalog Number : 900.11

Device Description : Load Distribution Cap, 11mm DIA.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B43690011350 Catalog Number : 900.11.35

Device Description : Sacroiliac Joint Fusion Implant, 11mm DIA. x 35mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

SiCure Sacroiliac Joint Fusion System - B43690011400 Catalog Number : 900.11.40

Device Description : Sacroiliac Joint Fusion Implant, 11mm DIA. x 40mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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