Liberty SI

FDA UDI

Class I (US FDA UDI)

by Spinal Simplicity, LLC

Identity

Trade Name: Liberty SI FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: Working Sleeve FDA UDI
Model / Reference: 20-0167-000 FDA UDI
Description: Working Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI: M9432001670000 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable 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

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: Orthopaedic implantation sleeve, reusable

Liberty SI by Spinal Simplicity, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic implantation sleeve, reusable.

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FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
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Jet-X — Smith & Nephew, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I

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: Spinal Simplicity, LLC

Sources (1)

FDA UDI a0b6d28b-1629-409f-b796-4bd205a4dd97 33 fields · synced Jun 9, 2026