Cadence™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Cadence™ FDA UDI
Generic Name: Ankle prosthesis trial, reusable FDA UDI
Device Name: Cadence Tibial Trial is used to verify proper implant placement and sizing. FDA UDI
Model / Reference: 10204172 FDA UDI
Description: Cadence Tibial Trial is used to verify proper implant placement and sizing. FDA UDI

Identifiers

Catalog Number: 10204172 FDA UDI
Primary DI / UDI-DI: 10381780356363 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Ankle prosthesis trial, 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: Ankle prosthesis trial, reusable

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

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XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class I
Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Vantage — Exactech, Inc. · Class I
Vantage®, Activit-E — Exactech, 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 5360347b-be6c-4340-8f88-9d4e5ca56c4e 37 fields · synced May 31, 2026