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Sign in to claim this brandALPHANOX CO., LTD.
US
Last updated May 23, 2026
What ALPHANOX CO., LTD. makes
Alphanox Co., Ltd. manufactures spinal fixation devices, including non-bioabsorbable bone screws, polymeric interbody fusion cages, internal and external fixation rods and plates, trial implants, reusable procedure kits, and sterilization containers. Their portfolio also covers spinal fixation systems with modular components, such as the 4CIS® Chiron Spinal Fixation System and the 4CIS VANE SPINE SYSTEM, designed for surgical stabilization of the spine.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) system. Alphanox Co., Ltd. is based in the United States, adhering to applicable regulatory requirements for spinal implants and surgical instrumentation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Alphanox Co., Ltd. manufacture?
Alphanox Co., Ltd. specializes in spinal fixation devices, which include non-bioabsorbable bone screws, polymeric spinal interbody fusion cages, internal and external spinal fixation rods and plates, trial implants, reusable procedure kits, and sterilization/disinfection containers. Their product portfolio also includes modular spinal fixation systems like the 4CIS® Chiron Spinal Fixation System and the 4CIS VANE SPINE SYSTEM, all designed for surgical stabilization of the spine.
Where is Alphanox Co., Ltd. based, and what regulatory requirements do they follow?
Alphanox Co., Ltd. is headquartered in the United States. Since their devices are spinal implants and surgical instrumentation, they must comply with U.S. regulatory standards, including those set by the FDA for device classification, manufacturing practices, and post-market surveillance. Compliance ensures their products meet safety, performance, and quality benchmarks for use in spinal surgeries.
Which regulatory registries list Alphanox Co., Ltd.’s devices?
Alphanox Co., Ltd.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify their spinal fixation products, ensuring transparency in the supply chain and aiding in post-market surveillance. The UDI system is a key tool for regulatory oversight and patient safety.
How are Alphanox Co., Ltd.’s devices classified under FDA regulations?
Alphanox Co., Ltd.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as spinal fixation hardware.
What does it mean for Alphanox Co., Ltd.’s devices to be listed in the FDA’s UDI system?
Listing in the FDA’s UDI system means each of Alphanox Co., Ltd.’s devices carries a unique identifier, combining a device identifier and a production identifier. This system improves traceability, reduces medical errors, and supports regulatory tracking of spinal implants throughout their lifecycle. It also helps healthcare providers and regulators quickly access critical information about the device, such as its design, manufacturing details, and potential recalls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 687844241
Catalogue (7612)
Page 28 of 153| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spinal Fusion Cage System | APU6-32QE | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | TPUA-3099 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4145-7050 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4147-8525 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4127-7025 | FDA UDI | Class II | Active |
| 4cis® Instrument System | 4901-8122 | FDA UDI | Class I | Active |
| 4CIS® Chiron Spinal Fixation System | 4129-8085 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MTU0-E128 | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4002-6040 | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4332-5855 | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | DPU0-30NL | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4128-7535 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4146-6530 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4128-8065 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MPE0-E14A | FDA UDI | Class II | Unknown |
| 4cis Vane Spine System | 4332-5708 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4124-7560 | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4002-8555 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MPU0-C128 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4149-5040 | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4302-5550 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MPUA-G146 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4347-5190 | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | TPU0-30B9 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4151-7075 | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | TPU5-359E | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4711-5575 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4149-90A5 | FDA UDI | Class II | Active |
| 4cis® Instrument System | 5901-0490 | FDA UDI | Class I | Active |
| 4CIS® Chiron Spinal Fixation System | 4147-5035 | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | DPUC-45JG | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4146-9545 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MPE0-E126 | FDA UDI | Class II | Unknown |
| 4CIS® Chiron Spinal Fixation System | 4137-4535 | FDA UDI | Class II | Active |
| 4cis® Instrument System | 5901-0310 | FDA UDI | Class I | Active |
| Spinal Fusion Cage System | TPU0-309D | FDA UDI | Class II | Active |
| 4cis® Instrument System | 5901-0461 | FDA UDI | Class I | Active |
| 4CIS® Chiron Spinal Fixation System | 4339-6125 | FDA UDI | Class II | Active |
| 4cis Vane Spine System | 4022-7030 | FDA UDI | Class II | Active |
| Spinal Fusion Cage System | TPUA-2898 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MTU5-E149 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4136-7040 | FDA UDI | Class II | Active |
| 4CIS® Marlin ACIF Cage SYSTEM | MPU0-C127 | FDA UDI | Class II | Active |
| 4cis® Instrument System | 5901-0482 | FDA UDI | Class I | Active |
| 4cis® Instrument System | 5901-3277 | FDA UDI | Class I | Active |
| 4CIS® Chiron Spinal Fixation System | 4149-6060 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4129-85E0 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4126-80B0 | FDA UDI | Class II | Active |
| 4CIS® Chiron Spinal Fixation System | 4147-8565 | FDA UDI | Class II | Active |
| 4cis® Instrument System | 5901-4320 | FDA UDI | Class I | Active |
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