Unity

FDA UDI

Class I (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name: UNITY FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: PLATE HOLDER ASSEMBLY, LONG ANTERIOR LUMBAR PLATE FDA UDI
Model / Reference: 43-0099 FDA UDI
Description: PLATE HOLDER ASSEMBLY, LONG ANTERIOR LUMBAR PLATE FDA UDI

Identifiers

Primary DI / UDI-DI: 18257200032372 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Category: Spinal fixation plate, non-bioabsorbable

Unity by Orthofix US LLC — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Orthofix US LLC

Sources (1)

FDA UDI 8839cca3-c789-4736-9675-55b608796806 34 fields · synced May 31, 2026