Identity
- Trade Name
- MENDEC SPINE HV FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. The device is disposable and sterile. FDA UDI
- Model / Reference
- 12C20H1 FDA UDI
- Description
- Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. The device is disposable and sterile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08031497003313 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
Mendec Spine Hv 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI cca1de2f-77ae-4f59-a997-0e722c085223 34 fields · synced Jun 8, 2026