Identity
- Trade Name
- Polarfix™ Facet Screw System FDA UDI
- Generic Name
- Tendon/ligament tunneller FDA UDI
- Model / Reference
- FS0080 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800037569776 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Tendon/ligament tunneller FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tendon/ligament tunneller
Polarfix™ Facet Screw System by CG MedTech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tendon/ligament tunneller.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI ff299d83-d184-4ca6-8806-eaa6280cde31 32 fields · synced May 30, 2026