Kheiron 34CR55655
by S.M.A.I.O
Kheiron 34CR55655 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 03701313009779), 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 | Number03701313009779 | Date23 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253802 | Date1 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 03701313009779
- FDA 510(k) database K253802
Across registries
- FDA 510(k) K253802 decided 1 Jul 2026 Active
- FDA GUDID UDI-DI 03701313009779 listed 23 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K253802
- Listed FDA GUDID 03701313009779
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- Withdrawn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
- 34CR55655
- Primary DI / UDI-DI
- 03701313009779
- 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
Similar devices
Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).
- CD HORIZON SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON ESSENCE™ Spinal System 45440004540 by MEDTRONIC SOFAMOR DANEK, INC.
- OpenLoc-L Spinal Fixation System by L&K Biomed
- M.U.S.T. Combined Set Screws by Medacta International S.A.
- Spinal Instrument 99741002 by Clariance, Inc.
- Sterispine™ PS by Safe Orthopaedics
- Erisma® Deformity Spinal System 18330010 by Clariance, Inc.
- USS ILIOSACRAL, USS POLYAXIAL by Synthes Spine
- GII Spinal Fixation System by coLigne AG
- PERLA ® TL TLF-R4 65 50-S by Spineart