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

Pin, Fixation, Smooth (HTY) (2) Pin, Fixation, Threaded (JDW) (2) Orthopedic Manual Surgical Instrument (LXH) (1) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

3.9 mm Headless Compression Screw Fastener - 00850015496233 Catalog Number : EX01-5039-50

Device Description : 3.9 mm Headless Compression Screw Fastener 50mm Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

K-Wire 0.9mm, Smooth, Single Trocar - 00850015496240 Catalog Number : EX01-0026

Device Description : K-Wire 0.9mm, Smooth, Single Trocar

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-Wire 0.9mm, 20mm Threaded, Single Trocar - 00850015496257 Catalog Number : EX01-0027

Device Description : K-Wire 0.9mm, 20mm Threaded, Single Trocar

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : JDW

Prescription Use : Yes

Device Count : 1

K-Wire 1.1mm, Smooth, Single Trocar - 00850015496264 Catalog Number : EX01-0028

Device Description : K-Wire 1.1mm, Smooth, Single Trocar

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

K-Wire 1.1mm, 20mm Threaded, Single Trocar - 00850015496271 Catalog Number : EX01-0029

Device Description : K-Wire 1.1mm, 20mm Threaded, Single Trocar

Device Class : 2

Duns Number: 089645059

Premarket Exempt : No

Product Code : JDW

Prescription Use : Yes

Device Count : 1

OsteoCentric Headless Compression Screw Fastener Depth Gauge - 00850015496288 Catalog Number : EX01-0004

Device Description : OsteoCentric Headless Compression Screw Fastener Depth Gauge Instrument

Device Class : 1

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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