Titan Modular Shoulder System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Titan Modular Shoulder System FDA UDI
Generic Name: Humeral body prosthesis trial FDA UDI
Device Name: DEFINITIVE STEM PRIMARY BODY TRIAL 14SML FDA UDI
Model / Reference: TRL-0920-120-14SML FDA UDI
Description: DEFINITIVE STEM PRIMARY BODY TRIAL 14SML FDA UDI

Identifiers

Catalog Number: T92012014SML FDA UDI
Primary DI / UDI-DI: 00885556862810 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Humeral body prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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: Humeral body prosthesis trial

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

Similar devices

Also classified as Humeral body prosthesis trial.

Equinoxe — Exactech, Inc. · Class II
SMR Shoulder — Limacorporate · Class II
Comprehensive Segmental Revision System (SRS) — Biomet Orthopedics, Inc. · Class II
Titan™ — Ascension Orthopedics, Inc. · Class I
Equinoxe — Exactech, Inc. · Class I
Equinoxe — Exactech, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
SMR Shoulder — Limacorporate · 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 f0e8a658-4b53-44f2-b4e6-dacf7ae249fa 35 fields · synced Jun 8, 2026