Alteon

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Alteon FDA UDI
Generic Name: Orthopaedic instrument extractor FDA UDI
Device Name: Special Taper Femoral Head Trial Remover, Handle FDA UDI
Model / Reference: SPI-012705 FDA UDI
Description: Special Taper Femoral Head Trial Remover, Handle FDA UDI

Identifiers

Catalog Number: SPI-012705 FDA UDI
Primary DI / UDI-DI: 10885862656100 FDA UDI
FDA Product Code: HWB FDA UDI
GMDN Term: Orthopaedic instrument extractor 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic instrument extractor

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

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Disassembler — ADLER ORTHO SPA · Class I

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: Exactech, Inc.

Sources (1)

FDA UDI dd982f0d-6e40-4723-a281-cffbf85ce0d9 34 fields · synced May 30, 2026