Identity
- Trade Name
- 4CIS APOLLON SPINE SYSTEM FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- Apollon Poly Pedicle Screw Driver FDA UDI
- Model / Reference
- 4901-3008 FDA UDI
- Description
- Apollon Poly Pedicle Screw Driver FDA UDI
Identifiers
- Catalog Number
- 4901-3008 FDA UDI
- Primary DI / UDI-DI
- 08806373526114 FDA UDI
- 510(k) Number
- K050471 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant driver
4cis Apollon Spine System by Alphanox Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050471 also covers:
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE SYSTEM — ALPHANOX CO., LTD.
- 4CIS SOLAR SPINE 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 |
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Manufacturer
- Manufacturer
- Alphanox Co., Ltd.
Sources (1)
- FDA UDI 29a63802-2a78-4400-915e-59b8e4d041a7 35 fields · synced May 30, 2026