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4CIS® Marlin ACIF Cage SYSTEM

FDA UDI

Class II (US FDA UDI)

by Alphanox Co., Ltd.

Identity

Trade Name
4CIS® Marlin ACIF Cage SYSTEM FDA UDI
Generic Name
Transfemoral amputation tissue-reinforcement implant trial FDA UDI
Device Name
4CIS® Marlin Trial 14x14, H10 FDA UDI
Model / Reference
5901-0158 FDA UDI
Description
4CIS® Marlin Trial 14x14, H10 FDA UDI

Identifiers

Catalog Number
5901-0158 FDA UDI
Primary DI / UDI-DI
08806373583414 FDA UDI
510(k) Number
K162402 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Transfemoral amputation tissue-reinforcement implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Transfemoral amputation tissue-reinforcement implant trial

4CIS® Marlin ACIF Cage SYSTEM by Alphanox Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transfemoral amputation tissue-reinforcement implant trial.

Cleared under the same submission

K162402 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphanox Co., Ltd.

Sources (1)

  • FDA UDI 5a1187b0-6857-437d-a0c9-73ac858cd146 35 fields · synced Jun 1, 2026