Identity
- Trade Name
- TFN-ADVANCE FDA UDI
- Generic Name
- Spiral blade FDA UDI
- Device Name
- TFNA FENESTRATED HELICAL BLADE 70MM FDA UDI
- Model / Reference
- 04.038.370 FDA UDI
- Description
- TFNA FENESTRATED HELICAL BLADE 70MM FDA UDI
Identifiers
- Catalog Number
- 04038370 FDA UDI
- Primary DI / UDI-DI
- 10886982099167 FDA UDI
- 510(k) Number
- K160167 FDA UDI
- FDA Product Code
- KTT FDA UDIHSB FDA UDI
- GMDN Term
- Spiral blade FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3020 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spiral blade
Tfn-Advance by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spiral blade.
- TFN-ADVANCE — Synthes · Class II
- EXPert Nail — Synthes · Class II
- DHHS — Synthes · Class II
- DHHS — Synthes · Class II
- TFN-ADVANCE — Synthes · Class II
- TFN-ADVANCE — Synthes · Class II
- TFN-ADVANCE — Synthes · Class II
- TFN-ADVANCE — Synthes · Class II
Cleared under the same submission
K160167 also covers:
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
- Synthes
Sources (1)
- FDA UDI fac64d31-c7ab-4bd8-b727-dea1e872ec35 36 fields · synced May 30, 2026