Lesinski

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Lesinski FDA UDI
Generic Name: Ossicular prosthesis, partial FDA UDI
Device Name: PROSTHESIS 0435 LESINSKI MOD LOOP 4.5MM FDA UDI
Model / Reference: 0435 FDA UDI
Description: PROSTHESIS 0435 LESINSKI MOD LOOP 4.5MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00681490023412 FDA UDI
510(k) Number: K823429 FDA UDI
FDA Product Code: LTB FDA UDI
GMDN Term: Ossicular prosthesis, partial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1235 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 — 4.5 Millimeter FDA UDI

Category: Ossicular prosthesis, partial

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

Similar devices

Also classified as Ossicular prosthesis, partial.

Partial Middle Ear Implant — Spiggle & Theis Medizintechnik GmbH · Class II
PRECISE CENTERED PARTIAL — Grace Medical, Inc. · Class II
SMART — Gyrus Acmi, Inc. · Class II
BARTELS BUCKET HANDLE — Grace Medical, Inc. · Class II
SATALOFF ALTO PARTIAL — Grace Medical, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
MatriX Stapes Prosthesis Titanium — Heinz Kurz · Class II
TITANIUM PISTON — Grace Medical, Inc. · Class II

Cleared under the same submission

K823429 also covers:

Fisch — MEDTRONIC XOMED, INC.

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 a169d8be-9f7b-46ee-8dc3-61874257b443 36 fields · synced May 31, 2026