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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
Polymeric spinal interbody fusion cage FDA UDI
Device Name
4CIS® Marlin PEEK ACIF Cage anatomical, Sterile, 12x12x5mm FDA UDI
Model / Reference
MPE0-C125 FDA UDI
Description
4CIS® Marlin PEEK ACIF Cage anatomical, Sterile, 12x12x5mm FDA UDI

Identifiers

Catalog Number
MPE0-C125 FDA UDI
Primary DI / UDI-DI
08806373584206 FDA UDI
510(k) Number
K162402 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

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 6fbb73d7-fae0-40a6-ab19-0646dcda60ed 36 fields · synced May 31, 2026