Identity
- Trade Name
- TEKTONA HV US Bone Cement FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. TEKTONA HV US Bone Cement is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile. FDA UDI
- Model / Reference
- TEK-BC HV US-S FDA UDI
- Description
- TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. TEKTONA HV US Bone Cement is a closed sysyem which containes the powder and liquid components separately. The device is disposable and sterile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497003351 FDA UDI
- 510(k) Number
- K122175 FDA UDI
- FDA Product Code
- NDN FDA UDILOD FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement preparation/delivery kit
TEKTONA HV US Bone Cement by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K122175 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
- Tecres
Sources (1)
- FDA UDI 78082db7-c814-44ea-8379-c793da2dca97 34 fields · synced Jun 8, 2026