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)

Premarket Exempt

No Yes

Clear

Valkyrie Thoracic Fixation System - 00810071390456 Catalog Number : 01-3010-2-HA-3

Device Description : HA Screw, Ø3.0 x 10mm (2-pack), Qty. 3

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390463 Catalog Number : 01-3013-4-HA-2

Device Description : HA Screw, Ø3.0 x 13mm (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 - 00810071390470 Catalog Number : 01-3013-4-HA-4

Device Description : HA Screw, Ø3.0 x 13mm (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 - 00810071390487 Catalog Number : 01-3013-2-HA-2

Device Description : HA Screw, Ø3.0 x 13mm (2-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 - 00810071390494 Catalog Number : 01-3013-2-HA-3

Device Description : HA Screw, Ø3.0 x 13mm (2-pack), Qty. 3

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390500 Catalog Number : 01-3015-4-HA-2

Device Description : HA Screw, Ø3.0 x 15mm (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 - 00810071390517 Catalog Number : 01-3015-4-HA-4

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

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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