Titan™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Titan™ FDA UDI
Generic Name: Humeral stem prosthesis trial, reusable FDA UDI
Device Name: The Definitive Stem Reverse Shoulder Body Trial is used to evaluate the size and fit of the implant. FDA UDI
Model / Reference: DTL096008STD FDA UDI
Description: The Definitive Stem Reverse Shoulder Body Trial is used to evaluate the size and fit of the implant. FDA UDI

Identifiers

Catalog Number: DTL-096-008STD FDA UDI
Primary DI / UDI-DI: 10381780235439 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Humeral stem prosthesis trial, reusable 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 stem prosthesis trial, reusable

Titan™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PRIMA — Limacorporate · Class I
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SMR Shoulder — Limacorporate · Class II
COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
Aequalis Reversed Fracture — TORNIER, 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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 1c0c407e-784f-489a-a6f0-44515d65cec3 37 fields · synced May 30, 2026