MatriX Stapes Prosthesis Titanium 1006025
by Heinz Kurz
MatriX Stapes Prosthesis Titanium 1006025 is a Class II device made by Heinz Kurz, cleared under FDA 510(k) K130512 on 2 Dec 2013 and listed in FDA GUDID since 21 Sep 2015 (UDI-DI EHKM10060251), active as of 22 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 | NumberEHKM10060251 | Date21 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130512 | Date2 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K130512
Across registries
- FDA 510(k) K130512 decided 2 Dec 2013 Active
- FDA GUDID UDI-DI EHKM10060251 listed 21 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K130512
- Listed FDA GUDID EHKM10060251
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MatriX Stapes Prosthesis Titanium
- Generic name
- Ossicular prosthesis, partial
- Model / Ref / Catalog
- 1006025
- Primary DI / UDI-DI
- EHKM10060251
- 510(k) Number
- FDA product code
- ETB
- GMDN term
- Ossicular prosthesis, partial
- Device class
- Class II
- Regulation number
- 874.3450
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional