Identity
- Trade Name
- 4CIS® Marlin ACIF Cage SYSTEM FDA UDI
- Generic Name
- Metallic spinal fusion cage, non-sterile FDA UDI
- Device Name
- 4CIS® Marlin Ti ACIF Cage anatomical, 16x14x7mm FDA UDI
- Model / Reference
- MTU0-G147 FDA UDI
- Description
- 4CIS® Marlin Ti ACIF Cage anatomical, 16x14x7mm FDA UDI
Identifiers
- Catalog Number
- MTU0-G147 FDA UDI
- Primary DI / UDI-DI
- 08806373582660 FDA UDI
- 510(k) Number
- K162402 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Metallic spinal fusion cage, non-sterile 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Metallic spinal fusion cage, non-sterile
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 Metallic spinal fusion cage, non-sterile.
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
- TraXis® — ZIMMER SPINE, INC. · Class II
- PLIF Cage — Eisertech, LLC · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
- Copperhead — EMINENT SPINE LLC · Class II
- SPIRA™-C Open Matrix Cervical Interbody — CAMBER SPINE TECHNOLOGIES · Class II
- IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K162402 also covers:
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
- 4CIS® Marlin ACIF Cage SYSTEM — ALPHANOX CO., LTD.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alphanox Co., Ltd.
Sources (1)
- FDA UDI c8ca0a42-2018-4827-80cc-9d560d5a4bc9 35 fields · synced May 31, 2026