Hintermann Series

FDA UDI

Class I (US FDA UDI)

by Dt Medtech, LLC

Identity

Trade Name: Hintermann Series FDA UDI
Generic Name: Ankle prosthesis trial, reusable FDA UDI
Device Name: Tibial Trial Right - Size 2 Instrument FDA UDI
Model / Reference: 1 FDA UDI
Description: Tibial Trial Right - Size 2 Instrument FDA UDI

Identifiers

Catalog Number: 129682 FDA UDI
Primary DI / UDI-DI: B095119692 FDA UDI
510(k) Number: K171004 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ankle prosthesis trial, reusable

Hintermann Series by Dt Medtech, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ankle prosthesis trial, reusable.

Cadence™ — Ascension Orthopedics, Inc. · Class I
INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Vantage®, Activit-E — Exactech, Inc. · Class I
Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Cadence™ — Ascension Orthopedics, Inc. · Class I
Cadence™ — Ascension Orthopedics, Inc. · Class I
XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class I
Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

Cleared under the same submission

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: Dt Medtech, LLC

Sources (1)

FDA UDI 387ead83-7c06-4f37-8185-5fe952faed11 36 fields · synced May 30, 2026