J.M. Longyear Manufacturing, 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) (9) Plate, Fixation, Bone (HRS) (1)

Premarket Exempt

Yes No

Clear

Valkyrie Thoracic Fixation System - 00810071390203 Catalog Number : 01-3513-HA

Device Description : HA Screw, Ø3.5 x 13mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390210 Catalog Number : 01-3008-4-HA

Device Description : HA Screw, Ø3.0 x 8mm (4-pack)

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390227 Catalog Number : 01-3015-HA

Device Description : HA Screw, Ø3.0 x 15mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390234 Catalog Number : 01-3515-HA

Device Description : HA Screw, Ø3.5 x 15mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390241 Catalog Number : 01-070

Device Description : Rectangle Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390258 Catalog Number : 01-3015-4-HA

Device Description : HA Screw, Ø3.0 x 15mm (4-pack)

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390265 Catalog Number : 01-3015-2-HA

Device Description : HA Screw, Ø3.0 x 8mm (4-pack)

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390425 Catalog Number : 01-3010-4-HA-2

Device Description : HA Screw, Ø3.0 x 10mm (4-pack), Qty. 2

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390432 Catalog Number : 01-3010-4-HA-4

Device Description : HA Screw, Ø3.0 x 10mm (4-pack), Qty. 4

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390449 Catalog Number : 01-3010-2-HA-2

Device Description : HA Screw, Ø3.0 x 10mm (2-pack), Qty. 2

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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