Austin

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Austin FDA UDI
Generic Name: Ossicular prosthesis, total FDA UDI
Device Name: PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD FDA UDI
Model / Reference: 1156305 FDA UDI
Description: PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD FDA UDI

Identifiers

Primary DI / UDI-DI: 00681490035477 FDA UDI
510(k) Number: K823441 FDA UDI
FDA Product Code: LBM FDA UDI
GMDN Term: Ossicular prosthesis, total FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 8.0 Millimeter FDA UDI

Category: Ossicular prosthesis, total

Austin by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ossicular prosthesis, total.

TTP-Tuebingen Type AERIAL Total Titanium — Heinz Kurz · Class II
PRECISE HA LITE TOTAL — Grace Medical, Inc. · Class II
TTP-Tuebingen Type AERIAL Total Titanium — Heinz Kurz · Class II
MNP Total Prosthesis Titanium — Heinz Kurz · Class II
Duesseldorf Type AERIAL Total Titanium — Heinz Kurz · Class II
WILDCAT FIXED LENGTH TOTAL, HOLLOW — Grace Medical, Inc. · Class II
PRECISE OFFSET TOTAL — Grace Medical, Inc. · Class II
Duesseldorf Type AERIAL Total Titanium — Heinz Kurz · Class II

Cleared under the same submission

K823441 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI f30668ba-9598-46d7-b314-e8de89ce05a1 36 fields · synced May 30, 2026