Identity
- Trade Name
- SMARTSET FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- SmartSet HV High Viscosity Bone Cement 40g FDA UDI
- Model / Reference
- 3092-040 FDA UDI
- Description
- SmartSet HV High Viscosity Bone Cement 40g FDA UDI
Identifiers
- Catalog Number
- 3092040 FDA UDI
- Primary DI / UDI-DI
- 10603295168331 FDA UDI
- FDA Product Code
- MBB FDA UDILOD 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
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, non-antimicrobial
Smartset by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement, non-antimicrobial.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- OSTEOPAL® — Heraeus Medical LLC · Class II
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- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSAL — SURGENTEC LLC · Class II
- PCD, VertaPlex — Stryker Corp. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
Cleared under the same submission
K023012 also covers:
K033563 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
- Depuy (ireland)
Sources (1)
- FDA UDI 61f94840-d101-4f45-8fa8-1104ef0054ba 37 fields · synced Jun 1, 2026