Icona Hip Stem 7261111
by Corin Ltd
Icona Hip Stem 7261111 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K241472 on 3 Oct 2024 and listed in FDA GUDID since 7 Apr 2025 (UDI-DI 05056139247293), 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 | Number05056139247293 | Date7 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241472 | Date3 Oct 2024 | StatusActive |
Official records
- AccessGUDID record 05056139247293
- FDA 510(k) database K241472
Across registries
- FDA 510(k) K241472 decided 3 Oct 2024 Active
- FDA GUDID UDI-DI 05056139247293 listed 7 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K241472
- Listed FDA GUDID 05056139247293
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Icona Hip Stem
- Generic name
- Optical surgical tracking system spatial marker, single-use
- Model / reference
- 7261111
- Primary DI / UDI-DI
- 05056139247293
- 510(k) Number
- FDA product code
- MEH, KWL, KWY, LZO
- GMDN term
- Optical surgical tracking system spatial marker, single-use
- Device class
- Class II
- Regulation number
- 888.3353, 888.3360, 888.3390
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- MRI safety
- MR Conditional
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