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Kheiron 34KR55000

by S.M.A.I.O

Kheiron 34KR55000 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 03701313009632), active as of 9 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

510(k) K253802

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03701313009632 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK253802 Date1 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253802 decided 1 Jul 2026 Active
  • FDA GUDID UDI-DI 03701313009632 listed 23 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253802
  2. Listed FDA GUDID 03701313009632

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kheiron
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
34KR55000
Primary DI / UDI-DI
03701313009632
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

Related devices

Cleared under the same submission (K253802)

and 8 more cleared under K253802

Similar devices

Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).

Other devices from S.M.A.I.O

See all devices from S.M.A.I.O →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (9, all answered No)