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) (4)

Premarket Exempt

Clear

SiCure Sacroiliac Joint Fusion System - B43690011450 Catalog Number : 900.11.45

Device Description : Sacroiliac Joint Fusion Implant, 11mm 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 - B43690011500 Catalog Number : 900.11.50

Device Description : Sacroiliac Joint Fusion Implant, 11mm 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 - B43690011550 Catalog Number : 900.11.55

Device Description : Sacroiliac Joint Fusion Implant, 11mm 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 - B43690011600 Catalog Number : 900.11.60

Device Description : Sacroiliac Joint Fusion Implant, 11mm DIA. x 60mm LGTH.

Device Class : 2

Duns Number: 080354484

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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