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) (7) Screwdriver (HXX) (3)

Premarket Exempt

No Yes

Clear

Valkyrie Thoracic Fixation System - 00810071390104 Catalog Number : 01-3013-4-HA

Device Description : HA Screw, Ø3.0 x 13mm (4-pack)

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390111 Catalog Number : 01-3013-2-HA

Device Description : HA Screw, Ø3.0 x 13mm (2-pack)

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390128 Catalog Number : 01-01-3035

Device Description : Driver Bit

Device Class : 1

Duns Number: 081307059

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390135 Catalog Number : 01-04-3035

Device Description : Driver Bit, Short

Device Class : 1

Duns Number: 081307059

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390142 Catalog Number : 01-05-3035

Device Description : Driver Bit, No Shoulder

Device Class : 1

Duns Number: 081307059

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390159 Catalog Number : 01-3008-HA

Device Description : HA Screw, Ø3.0 x 8mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390166 Catalog Number : 01-3010-HA

Device Description : HA Screw, Ø3.0 x 10mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390173 Catalog Number : 01-3013-HA

Device Description : HA Screw, Ø3.0 x 13mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390180 Catalog Number : 01-3508-HA

Device Description : HA Screw, Ø3.5 x 8mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390197 Catalog Number : 01-3510-HA

Device Description : HA Screw, Ø3.5 x 10mm

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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