Alteon

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Alteon FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: ALT HA L DMND BRCH SZ 1 FDA UDI
Model / Reference: 191-12-01 FDA UDI
Description: ALT HA L DMND BRCH SZ 1 FDA UDI

Identifiers

Catalog Number: 191-12-01 FDA UDI
Primary DI / UDI-DI: 10885862513915 FDA UDI
510(k) Number: K162732 FDA UDI
FDA Product Code: MEH FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

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: Orthopaedic broach

Alteon by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic broach.

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Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II
APEX Knee System — OMNIlife science, Inc. · Class I

Cleared under the same submission

K162732 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: Exactech, Inc.

Sources (1)

FDA UDI 032cdf37-548c-443e-8571-eeb084804254 36 fields · synced Jun 6, 2026