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Kheiron 34SR60400

by S.M.A.I.O

Kheiron 34SR60400 is a Class II device made by S.M.A.I.O, listed in FDA GUDID since 23 Oct 2026 (UDI-DI 03701313009663), registry data as of 9 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03701313009663 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Kheiron
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
34SR60400
Primary DI / UDI-DI
03701313009663
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).

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)