Identity
- Trade Name
- Cellbrick Knee Spacer FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Device Name
- Tibial spacer mold, #2 FDA UDI
- Model / Reference
- 9909-5420 FDA UDI
- Description
- Tibial spacer mold, #2 FDA UDI
Identifiers
- Catalog Number
- 9909-5420 FDA UDI
- Primary DI / UDI-DI
- 04719886906189 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement spacer mould
Cellbrick Knee Spacer by United Orthopedic Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement spacer mould.
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- CeMend 10-48 mold insert press — G21 SRL · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI 399aa3ab-061e-4a8a-a3b9-4c38422b6224 35 fields · synced May 30, 2026