Valkyrie Thoracic Fixation System

FDA UDI

Class II (US FDA UDI)

by J.M. Longyear Manufacturing, LLC

Identity

Trade Name: Valkyrie Thoracic Fixation System FDA UDI
Generic Name: Sternal fixation device FDA UDI
Device Name: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 2 FDA UDI
Model / Reference: 01-3013-2-HA-2 FDA UDI
Description: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 2 FDA UDI

Identifiers

Catalog Number: 01-3013-2-HA-2 FDA UDI
Primary DI / UDI-DI: 00810071390784 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Sternal fixation device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Sternal fixation device

Valkyrie Thoracic Fixation System by J.M. Longyear Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sternal fixation device.

STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Vanguard® — Biomet Orthopedics, Inc. · Class I
ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
STERNALOCK® SYSTEM — BIOMET MICROFIXATION, INC · Class II
ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: J.M. Longyear Manufacturing, LLC

Sources (1)

FDA UDI f1c0bbec-2a1c-48e8-bc47-79129ed4cb53 34 fields · synced Jun 8, 2026