MagnetOs 703-057-US
MagnetOs 703-057-US is a Class II device made by Kuros Biosciences B.V, cleared under FDA 510(k) K233245 on 21 Nov 2023 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2022 (UDI-DI 08719699712171), 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 | FDA 510(k)SESE | NumberK233245 | Date21 Nov 2023 | StatusActive |
| United States | GUDID listing | Number08719699712171 | Date21 Sep 2022 | StatusListed |
Official records
- AccessGUDID record 08719699712171
- FDA 510(k) database K233245
- FDA 510(k) database K213959
Across registries
- FDA 510(k) K233245 decided 21 Nov 2023 Active
- FDA GUDID UDI-DI 08719699712171 listed 21 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K213959
- Listed FDA GUDID 08719699712171
- Cleared FDA 510(k) K233245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MagnetOs
- Generic name
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Model / reference
- 703-057-US
- Primary DI / UDI-DI
- 08719699712171
- FDA product code
- MQV
- GMDN term
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
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