Titan Reverse Shoulder System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Titan Reverse Shoulder System FDA UDI
Generic Name: Reverse shoulder head prosthesis trial FDA UDI
Device Name: RSS GLENOSPHERE TRIAL. ECCENTRIC-S FDA UDI
Model / Reference: TRL-0961-05E-S FDA UDI
Description: RSS GLENOSPHERE TRIAL. ECCENTRIC-S FDA UDI

Identifiers

Catalog Number: TRL-0961-05E-S FDA UDI
Primary DI / UDI-DI: 00885556864814 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Reverse shoulder head prosthesis trial 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: Reverse shoulder head prosthesis trial

Titan Reverse Shoulder System by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder head prosthesis trial.

Equinoxe — Exactech, Inc. · Class I
ProMade Shoulder — Limacorporate · Class I
AGILON® XO trial glenosphere — implantcast GmbH · Class II
AGILON® XO trial cap inverse — implantcast GmbH · Class II
Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
SMR Shoulder - Hybrid Glenoid — Limacorporate · Class II
REUNION — Stryker Corp. · Class II
Arthrex® — Arthrex, 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI d040854b-339f-4c95-8dc7-e911706e75d6 35 fields · synced Jun 8, 2026