J.M. Longyear Manufacturing, LLC

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

Plate, Fixation, Bone (HRS) (8) Screw, Fixation, Bone (HWC) (2)

Premarket Exempt

No Yes

Clear

Valkyrie Thoracic Fixation System - 00810071390005 Catalog Number : 01-010

Device Description : V-Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390012 Catalog Number : 01-020

Device Description : X-Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390029 Catalog Number : 01-030

Device Description : M-Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390036 Catalog Number : 01-040

Device Description : T-Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390043 Catalog Number : 01-050

Device Description : Box Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390050 Catalog Number : 01-060

Device Description : Ladder Plate

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390067 Catalog Number : 01-100-08

Device Description : Straight Plate 8-hole

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390074 Catalog Number : 01-100-16

Device Description : Straight Plate 16-hole

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390081 Catalog Number : 01-3010-4-HA

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

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Valkyrie Thoracic Fixation System - 00810071390098 Catalog Number : 01-3010-2-HA

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

Device Class : 2

Duns Number: 081307059

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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