SMV SCIENTIFIC LLC

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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

Screw, Fixation, Bone (HWC) (10)

Premarket Exempt

No Yes

Clear

2.8 mm Headless Compression Screw Fastener - 00850015496035 Catalog Number : EX01-5028-16

Device Description : 2.8 mm Headless Compression Screw Fastener 16mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496042 Catalog Number : EX01-5028-18

Device Description : 2.8 mm Headless Compression Screw Fastener 18mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496059 Catalog Number : EX01-5028-20

Device Description : 2.8 mm Headless Compression Screw Fastener 20mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496066 Catalog Number : EX01-5028-22

Device Description : 2.8 mm Headless Compression Screw Fastener 22mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496073 Catalog Number : EX01-5028-24

Device Description : 2.8 mm Headless Compression Screw Fastener 24mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496080 Catalog Number : EX01-5028-26

Device Description : 2.8 mm Headless Compression Screw Fastener 26mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496097 Catalog Number : EX01-5028-28

Device Description : 2.8 mm Headless Compression Screw Fastener 28mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

2.8 mm Headless Compression Screw Fastener - 00850015496103 Catalog Number : EX01-5028-30

Device Description : 2.8 mm Headless Compression Screw Fastener 30mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

3.9 mm Headless Compression Screw Fastener - 00850015496110 Catalog Number : EX01-5039-16

Device Description : 3.9 mm Headless Compression Screw Fastener 16mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

3.9 mm Headless Compression Screw Fastener - 00850015496127 Catalog Number : EX01-5039-18

Device Description : 3.9 mm Headless Compression Screw Fastener 18mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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