Alteon

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Alteon FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Device Name: Alteon Short Tapered Wedge Stem, Standard Offset, Size 4 FDA UDI
Model / Reference: 188-30-04 FDA UDI
Description: Alteon Short Tapered Wedge Stem, Standard Offset, Size 4 FDA UDI

Identifiers

Catalog Number: 188-30-04 FDA UDI
Primary DI / UDI-DI: 10885862602664 FDA UDI
510(k) Number: K221323 FDA UDI
FDA Product Code: LZO FDA UDI
GMDN Term: Press-fit femoral stem prosthesis 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Press-fit femoral stem prosthesis

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

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BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Accolade — Howmedica Osteonics Corp. · Class II
BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K221323 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 348c597f-394a-4796-8bc8-ec1e4920a3e4 35 fields · synced Jun 8, 2026