Kheiron 34CR55445
by S.M.A.I.O
Kheiron 34CR55445 is a Class II device made by S.M.A.I.O, cleared under FDA 510(k) K253802 on 1 Jul 2026 and listed in FDA GUDID since 23 Oct 2026 (UDI-DI 03701313009809), active as of 9 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 | Number03701313009809 | Date23 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253802 | Date1 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 03701313009809
- FDA 510(k) database K253802
Across registries
- FDA 510(k) K253802 decided 1 Jul 2026 Active
- FDA GUDID UDI-DI 03701313009809 listed 23 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K253802
- Listed FDA GUDID 03701313009809
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kheiron
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 34CR55445
- Primary DI / UDI-DI
- 03701313009809
- 510(k) Number
- FDA product code
- NKB
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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