Ti-MESH 6000470
Ti-MESH 6000470 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 04042301102768), 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 | Number04042301102768 | Date1 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031225 | Date29 Sep 2003 | StatusActive |
Official records
- AccessGUDID record 04042301102768
- FDA 510(k) database K031225
Across registries
- FDA 510(k) K031225 decided 29 Sep 2003 Active
- FDA GUDID UDI-DI 04042301102768 listed 1 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K031225
- Listed FDA GUDID 04042301102768
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- Withdrawn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
- 6000470
- Primary DI / UDI-DI
- 04042301102768
- 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
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