Identity
- Trade Name
- CeMend 48mm head insert FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Model / Reference
- AR-902-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08058964728968 FDA UDI
- 510(k) Number
- K202338 FDA UDI
- FDA Product Code
- MBB FDA UDIHSD FDA UDIKWS FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.3690 FDA UDI888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement spacer mould
CeMend 48mm head insert by G21 Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement spacer mould.
- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
- STAGEONE — Biomet Orthopedics, Inc. · Class II
- SURESPACE — ORTHO DEVELOPMENT CORP. · Class II
- StageOne Select — Biomet Orthopedics, Inc. · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- STAGEONE — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K202338 also covers:
- CeMend 10-42 mold insert press — G21 SRL
- CeMend 10-48 mold insert press — G21 SRL
- CeMend 12-42 mold insert press — G21 SRL
- CeMend 12-48 mold insert press — G21 SRL
- CeMend 14-48 mold insert press — G21 SRL
- CeMend 42mm head insert — G21 SRL
- CeMend 8-42 mold insert press — G21 SRL
- CeMend Base Compression Bolt — G21 SRL
- CeMend Mold Base — G21 SRL
- CeMend Shoulder Mold Tray — G21 SRL
- CeMend Shoulder Spacer Mold — G21 SRL
- CeMend Shoulder Spacer Mold — G21 SRL
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
- G21 Srl
Sources (1)
- FDA UDI 70e6a451-df76-4763-9f29-89e3ff46501a 33 fields · synced May 30, 2026