FDA.reportPublic FDA data

Valkyrie Thoracic Fixation System

Primary DI
00810071390623
Brand
Valkyrie Thoracic Fixation System
Company
J.M. Longyear Manufacturing, LLC
Model
01-100-08
Catalog number
01-100-08
Device description
Straight Plate 8-hole
Published
2022-12-08
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
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202889000Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021-03-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071390623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071390623008100713906238100713906230810071390623

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.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01