Smartset 3092-020
Smartset 3092-020 (3092020) is a Class II device made by Depuy (Ireland), cleared under FDA 510(k) K033563 on 5 Feb 2004 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295168324), active as of 9 Nov 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10603295168324 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033563 | Date5 Feb 2004 | StatusActive |
Official records
- AccessGUDID record 10603295168324
- FDA 510(k) database K033563
- FDA 510(k) database K023012
Across registries
- FDA 510(k) K033563 decided 5 Feb 2004 Active
- FDA GUDID UDI-DI 10603295168324 listed 24 Sep 2015 Listed
Recalls
-
- Terminated Z-1246-2015
One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
Timeline
- Cleared FDA 510(k) K023012
- Cleared FDA 510(k) K033563
- Recall initiated FDA recalls Z-1246-2015
- Listed FDA GUDID 10603295168324
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smartset
- Generic name
- Orthopaedic cement, non-antimicrobial
- Model / Ref / Catalog
- 3092-020, 3092020
- Primary DI / UDI-DI
- 10603295168324
- FDA product code
- MBB, LOD
- GMDN term
- Orthopaedic cement, non-antimicrobial
- Device class
- Class II
- Regulation number
- 888.3027
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Orthopaedic cement, non-antimicrobial.