SMV SCIENTIFIC LLC

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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

No Yes

Clear

10 x 50mm Anodized SI Implant - 00810097800083 Catalog Number : 1252-1010-050

Device Description : 10 x 50mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 55mm Anodized SI Implant - 00810097800090 Catalog Number : 1252-1010-055

Device Description : 10 x 55mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 60mm Anodized SI Implant - 00810097800106 Catalog Number : 1252-1010-060

Device Description : 10 x 60mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 65mm Anodized SI Implant - 00810097800113 Catalog Number : 1252-1010-065

Device Description : 10 x 65mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 70mm Anodized SI Implant - 00810097800120 Catalog Number : 1252-1010-070

Device Description : 10 x 70mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 75mm Anodized SI Implant - 00810097800137 Catalog Number : 1252-1010-075

Device Description : 10 x 75mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 80mm Anodized SI Implant - 00810097800144 Catalog Number : 1252-1010-080

Device Description : 10 x 80mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

10 x 85mm Anodized SI Implant - 00810097800151 Catalog Number : 1252-1010-085

Device Description : 10 x 85mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.5 x 30mm Biomechanical Screw - 00810097800168 Catalog Number : 1252-0006-030

Device Description : 6.5 x 30mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.5 x 35mm Biomechanical Screw - 00810097800175 Catalog Number : 1252-0006-035

Device Description : 6.5 x 35mm Biomechanical Screw

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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