Identity
- Trade Name
- CEMEX SYSTEM FAST 40G FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex System Fast 40g is indicated for the fixation of joint prosthesis implants to the host bone. FDA UDI
- Model / Reference
- 13A2020 FDA UDI
- Description
- Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex System Fast 40g is indicated for the fixation of joint prosthesis implants to the host bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497001399 FDA UDI
- 510(k) Number
- K031430 FDA UDI
- FDA Product Code
- LOD 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
Cemex System Fast 40g by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement preparation/delivery kit.
- PicoMix Syringe — G21 SRL · Class I
- MEDINAUT-Ix — IMEDICOM CO., LTD. · Class I
- Arthrex Bone Cement Mixing Syringe — G21 SRL · Class I
- Revolution — Stryker Corp. · Class I
- LITe BIO Delivery System — Stryker Corp. · Class II
- VORTEX — Smith & Nephew, Inc. · Class I
- StabiliT® — Merit Medical Systems, Inc. · Class II
- PicoMix Bowl — G21 SRL · Class I
Cleared under the same submission
K031430 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 955a53c0-9e52-45b9-9ccd-776038ea33a3 34 fields · synced Jun 8, 2026