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: Talar Trial Implant Right - Size 1 Instrument FDA UDI
Model / Reference: 1 FDA UDI
Description: Talar Trial Implant Right - Size 1 Instrument FDA UDI

Identifiers

Catalog Number: 319681 FDA UDI
Primary DI / UDI-DI: B095319681 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

MRI Safety

MR Conditional 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 4e5387c7-cd93-47ef-8d05-14821d5adcf9 36 fields · synced Jun 8, 2026