Alteon

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Alteon FDA UDI
Generic Name: Coated femoral stem prosthesis, modular FDA UDI
Model / Reference: 190-10-02 FDA UDI

Identifiers

Catalog Number: 190-10-02 FDA UDI
Primary DI / UDI-DI: 10885862321527 FDA UDI
510(k) Number: K162732 FDA UDI
FDA Product Code: MEH FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated femoral stem prosthesis, modular

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

Similar devices

Also classified as Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
Origin DAA Stem, Coxa Vara — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

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 360cc63e-db24-4fe4-8a74-cb440c248c85 35 fields · synced Jun 8, 2026