FDA.reportPublic FDA data

Valkyrie Thoracic Fixation System

Primary DI
00810071390692
Brand
Valkyrie Thoracic Fixation System
Company
J.M. Longyear Manufacturing, LLC
Model
01-3013-2-HA
Catalog number
01-3013-2-HA
Device description
HA Screw, Ø3.0 x 13mm (2-pack)
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071390692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071390692008100713906928100713906920810071390692

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Regulatory Flags#

DUNS number
081307059
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810071391460Able Medical Devices01-08-303501-08-30352026-05-26
00810071390845Valkyrie Rib Thoracic Fixation System05-000-0805-000-082023-12-20
00810071390852Valkyrie Rib Thoracic Fixation System05-500-1205-500-122023-12-20
00810071390869Valkyrie Rib Thoracic Fixation System05-300-1605-300-162023-12-20
00810071390883Valkyrie Rib Thoracic Fixation System05-2507-105-2507-12023-12-20
00810071390890Valkyrie Rib Thoracic Fixation System05-2507-305-2507-32023-12-20
00810071390906Valkyrie Rib Thoracic Fixation System05-2507-805-2507-82023-12-20
00810071390944Valkyrie Rib Thoracic Fixation System05-2509-105-2509-12023-12-20
00810071390951Valkyrie Rib Thoracic Fixation System05-2509-305-2509-32023-12-20
00810071390968Valkyrie Rib Thoracic Fixation System05-2509-805-2509-82023-12-20
00810071391002Valkyrie Rib Thoracic Fixation System05-2511-105-2511-12023-12-20
00810071391019Valkyrie Rib Thoracic Fixation System05-2511-305-2511-32023-12-20
00810071391026Valkyrie Rib Thoracic Fixation System05-2511-805-2511-82023-12-20
00810071391064Valkyrie Rib Thoracic Fixation System05-2513-105-2513-12023-12-20
00810071391071Valkyrie Rib Thoracic Fixation System05-2513-305-2513-32023-12-20
00810071391088Valkyrie Rib Thoracic Fixation System05-2513-805-2513-82023-12-20
00810071391125Valkyrie Rib Thoracic Fixation System05-2515-105-2515-12023-12-20
00810071391132Valkyrie Rib Thoracic Fixation System05-2515-305-2515-32023-12-20
00810071391149Valkyrie Rib Thoracic Fixation System05-2515-805-2515-82023-12-20
00810071391156Valkyrie Rib Thoracic Fixation System05-2807-105-2807-12023-12-20

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Primary DI, Brand, Company table
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