Identity
- Trade Name
- TiWave C Cervical Cage System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Cervical Trial, Flat, 16x14, 6mm, 14 degree Extra Tapered FDA UDI
- Model / Reference
- 20-TFX-6406 FDA UDI
- Description
- Cervical Trial, Flat, 16x14, 6mm, 14 degree Extra Tapered FDA UDI
Identifiers
- Primary DI / UDI-DI
- B07320TFX64060 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
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: Spinal implant trial
TiWave C Cervical Cage System by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ROI-A — Ldr Spine USA · Class II
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
- Kalitec Direct LLC
Sources (1)
- FDA UDI 525f6502-d106-4654-afd0-bf6342751274 33 fields · synced May 29, 2026