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 Biased Insert Trial Extension is used to verify proper implant placement and sizing for patients with either an anterior or posterior subluxed talus FDA UDI
Model / Reference: 10205005 FDA UDI
Description: Cadence Biased Insert Trial Extension is used to verify proper implant placement and sizing for patients with either an anterior or posterior subluxed talus FDA UDI

Identifiers

Catalog Number: 10205005 FDA UDI
Primary DI / UDI-DI: 10381780240839 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

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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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
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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 2be1decb-c0eb-4bf8-aa55-8faea801d563 37 fields · synced May 31, 2026