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Acs®

FDA UDI

Class I (US FDA UDI)

by implantcast GmbH

Identity

Trade Name
ACS® FDA UDI
Generic Name
Knee femur prosthesis trial, reusable FDA UDI
Device Name
femoral trial component left FDA UDI
Model / Reference
42103104 FDA UDI
Description
femoral trial component left FDA UDI

Identifiers

Primary DI / UDI-DI
04048844037758 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee femur prosthesis trial, reusable

ACS is a reusable femoral trial component designed for unicompartmental knee replacement surgery or total knee arthroplasty (TKA). It is one of a set, or a set, of graduated sizes, typically made of metal or polymer material. This device includes various trials to determine the correct alignment, size, and fit of the final prosthesis.

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
implantcast GmbH

Sources (1)

  • FDA UDI 8d9aeaec-74cd-4210-889d-4da150316db7 34 fields · synced Jul 6, 2026