Endohead 01.25.240M
Endohead 01.25.240M is a Class II device made by Medacta International SA, cleared under FDA 510(k) K111145 on 16 Aug 2011 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030806216), active as of 12 Nov 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 | Number07630030806216 | Date18 Nov 2014 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111145 | Date16 Aug 2011 | StatusActive |
Official records
- AccessGUDID record 07630030806216
- FDA 510(k) database K111145
Across registries
- FDA 510(k) K111145 decided 16 Aug 2011 Active
- FDA GUDID UDI-DI 07630030806216 listed 18 Nov 2014 Listed
Timeline
- Cleared FDA 510(k) K111145
- Listed FDA GUDID 07630030806216
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Endohead
- Generic name
- Bipolar femoral head outer component, hemiarthroplasty
- Model / reference
- 01.25.240M
- Primary DI / UDI-DI
- 07630030806216
- 510(k) Number
- FDA product code
- LZY
- GMDN term
- Bipolar femoral head outer component, hemiarthroplasty
- Device class
- Class II
- Regulation number
- 888.3360
- GUDID distribution status
- In Commercial Distribution
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