Smartset 3102-080
Smartset 3102-080 (3102080) is a Class I device made by Depuy (Ireland), cleared under FDA 510(k) K042591 on 22 Oct 2004 (2 earlier submissions), approved under FDA PMA P960001 on 11 Feb 1997 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295168355), active as of 9 Nov 2026.
Active
PMA 510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10603295168355 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042591 | Date22 Oct 2004 | StatusActive |
| United States | FDA PMAAPRL | NumberP960001 | Date11 Feb 1997 | StatusActive |
Official records
- AccessGUDID record 10603295168355
- FDA 510(k) database K042591
- FDA 510(k) database K041656
- FDA 510(k) database K033382
- FDA PMA database P960001
Across registries
- FDA 510(k) K042591 decided 22 Oct 2004 Active
- FDA PMA P960001 decided 11 Feb 1997 Active
- FDA GUDID UDI-DI 10603295168355 listed 24 Sep 2015 Listed
Timeline
- Approved FDA PMA P960001
- Cleared FDA 510(k) K033382
- Cleared FDA 510(k) K041656
- Cleared FDA 510(k) K042591
- Listed FDA GUDID 10603295168355
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k), FDA PMA Active
Specification
- Trade name
- Smartset
- Generic name
- Orthopaedic cement, non-antimicrobial
- Model / Ref / Catalog
- 3102-080, 3102080
- Primary DI / UDI-DI
- 10603295168355
- PMA number
- FDA product code
- KIH, MBB, LOD, JDZ
- GMDN term
- Orthopaedic cement, non-antimicrobial
- Device class
- Class I
- Regulation number
- 888.4200, 888.3027, 888.4210
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic cement, non-antimicrobial.