Hallmark

FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name: HALLMARK FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: 14mm Semi-Constrained Rescue Bone Screw FDA UDI
Model / Reference: 62-4140 FDA UDI
Description: 14mm Semi-Constrained Rescue Bone Screw FDA UDI

Identifiers

Primary DI / UDI-DI: 18257200017782 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 14 Millimeter FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Hallmark by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

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TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · 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: Orthofix US LLC

Sources (1)

FDA UDI d6763b96-5cfb-4cf2-a2c0-28bce5e23541 35 fields · synced May 31, 2026