Agilon®

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: AGILON® FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: osteotomy guide 140° FDA UDI
Model / Reference: 78010240 FDA UDI
Description: osteotomy guide 140° FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844620097 FDA UDI
FDA Product Code: HSD FDA UDI
PHX FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 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

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 fixation implant alignment tool

Agilon® by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: implantcast GmbH

Sources (1)

FDA UDI 84027062-021c-434d-852c-1a3736c9b07d 33 fields · synced May 30, 2026