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) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

2.70 Guide Wire Drill Tip SS 450mm - 00810074300384 Catalog Number : 2004-0028

Device Description : 2.70 Stainless Steel Guide Wire Drill Tip 450mm long

Device Class : 1

Duns Number: 089645059

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

2.70 Guide Wire Thd SS 450mm - 00810074300391 Catalog Number : 2004-0029

Device Description : 2.70 Stainless Steel Guide Wire Threaded Tip 450mm long

Device Class : 1

Duns Number: 089645059

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

12 x 50mm Anodized SI Implant - 00810097800007 Catalog Number : 1252-1012-050

Device Description : 12 x 50mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 55mm Anodized SI Implant - 00810097800014 Catalog Number : 1252-1012-055

Device Description : 12 x 55mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 60mm Anodized SI Implant - 00810097800021 Catalog Number : 1252-1012-060

Device Description : 12 x 60mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 65mm Anodized SI Implant - 00810097800038 Catalog Number : 1252-1012-065

Device Description : 12 x 65mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 70mm Anodized SI Implant - 00810097800045 Catalog Number : 1252-1012-070

Device Description : 12 x 70mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 75mm Anodized SI Implant - 00810097800052 Catalog Number : 1252-1012-075

Device Description : 12 x 75mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 80mm Anodized SI Implant - 00810097800069 Catalog Number : 1252-1012-080

Device Description : 12 x 80mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12 x 85mm Anodized SI Implant - 00810097800076 Catalog Number : 1252-1012-085

Device Description : 12 x 85mm Anodized SI Implant

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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