Alteon

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Alteon FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: Alteon Cup FDA UDI
Model / Reference: 01-030-01-0348 FDA UDI
Description: Alteon Cup FDA UDI

Identifiers

Catalog Number: 01-030-01-0348 FDA UDI
Primary DI / UDI-DI: 10885862549174 FDA UDI
510(k) Number: K182502 FDA UDI
FDA Product Code: JDI FDA UDI
OQI FDA UDI
LPH FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3353 FDA UDI
888.3358 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

Dimensions & Sizes

Size: Outer Diameter — 48 Millimeter FDA UDI

Category: Acetabular shell

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

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Cleared under the same submission

K182502 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 1a95e7bb-e88e-4a3b-8e70-a52bc1d0cce0 36 fields · synced May 31, 2026