Identity
- Trade Name
- 4CIS® Chiron Spinal Fixation System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 4CIS® Chiron Poly Reduction Screw Ø6.5 X 65mm (Rod Ø6.0) FDA UDI
- Model / Reference
- 4149-6565 FDA UDI
- Description
- 4CIS® Chiron Poly Reduction Screw Ø6.5 X 65mm (Rod Ø6.0) FDA UDI
Identifiers
- Catalog Number
- 4149-6565 FDA UDI
- Primary DI / UDI-DI
- 08800033327318 FDA UDI
- 510(k) Number
- K190471 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
4CIS® Chiron Spinal Fixation System by Alphanox Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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- EVEREST® Spinal System — K2M, INC. · Class II
Cleared under the same submission
K190471 also covers:
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD.
- 4CIS® Chiron Spinal Fixation 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 d304ec78-b51a-4397-934a-4f079a589954 35 fields · synced May 29, 2026