Identity
- Trade Name
- Cemex Prep Kit FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Cemex Prep kit is intended to be used for helping the surgeons during the fixation of artificial joint prostheses with the acrylic bone cement. The device contains a number of accessories useful during a prosthesis implantation surgery performed using the cementing technique. The components are packaged all together in a unique sterile package single-use. FDA UDI
- Model / Reference
- KIT-01 FDA UDI
- Description
- Cemex Prep kit is intended to be used for helping the surgeons during the fixation of artificial joint prostheses with the acrylic bone cement. The device contains a number of accessories useful during a prosthesis implantation surgery performed using the cementing technique. The components are packaged all together in a unique sterile package single-use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497000323 FDA UDI
- 510(k) Number
- K021765 FDA UDI
- FDA Product Code
- JDK FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
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 Prep Kit by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement preparation/delivery kit.
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- 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
K021765 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 f8505452-a5b3-4f88-b2a8-5e33e9a512f5 34 fields · synced Jun 8, 2026