FDA.reportPublic FDA data

Valkyrie Rib Thoracic Fixation System

Primary DI
00810071391002
Brand
Valkyrie Rib Thoracic Fixation System
Company
J.M. Longyear Manufacturing, LLC
Model
05-2511-1
Catalog number
05-2511-1
Device description
Rib Screw, Ø2.5 x 11mm, Qty. 1
Published
2023-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
00810071391002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071391002008100713910028100713910020810071391002

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., surgical steel).

Sterilization Methods#

Method table
Method

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
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
00810071391163Valkyrie Rib Thoracic Fixation System05-2807-305-2807-32023-12-20

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