ACS® Uni femoral alignment guide extramedullary

FDA UDI

Class I (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: ACS® Uni femoral alignment guide extramedullary FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Model / Reference: 42160711 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844233587 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool 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

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

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

ACS® Uni femoral alignment guide extramedullary by implantcast GmbH — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: implantcast GmbH

Sources (1)

FDA UDI d37426f8-65fc-4520-a267-a440a2e55d6d 32 fields · synced Jun 1, 2026