Identity
- Trade Name
- Mendec Spine FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application. The device is sold disposable and sterile FDA UDI
- Model / Reference
- 1230 FDA UDI
- Description
- Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application. The device is sold disposable and sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497000101 FDA UDI
- FDA Product Code
- NDN FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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, non-antimicrobial
Mendec Spine by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 1c2e0d87-cfc4-49ef-b410-6e12cc944fa7 33 fields · synced Jun 8, 2026