Ti-MESH 6000311
Ti-MESH 6000311 is a Class II device made by pfm medical titanium gmbh, cleared under FDA 510(k) K031225 on 29 Sep 2003 and listed in FDA GUDID since 1 Nov 2021 (UDI-DI 04042301097583), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04042301097583 | Date1 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031225 | Date29 Sep 2003 | StatusActive |
Official records
- AccessGUDID record 04042301097583
- FDA 510(k) database K031225
Across registries
- FDA 510(k) K031225 decided 29 Sep 2003 Active
- FDA GUDID UDI-DI 04042301097583 listed 1 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K031225
- Listed FDA GUDID 04042301097583
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ti-MESH
- Generic name
- Extra-gynaecological surgical mesh, composite-polymer
- Model / reference
- 6000311
- Primary DI / UDI-DI
- 04042301097583
- 510(k) Number
- FDA product code
- FTL, OXJ
- GMDN term
- Extra-gynaecological surgical mesh, composite-polymer
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Extra-gynaecological surgical mesh, composite-polymer.
- PROCEED PVPS by Johnson & Johnson International Inc.
- Parietex PCOPM15H50 by SOFRADIM PRODUCTION
- PROCEED PVPM by Johnson & Johnson International Inc.
- Parietex PCO4VP by SOFRADIM PRODUCTION
- Biomesh® CA.B.S.’Air® Composite CABST1R05T by Cousin Biotech Sas
- Biomesh® CA.B.S.’Air® Composite CABSAIRC7 by Cousin Biotech Sas