Skip to content

Kheiron 28IW95075

by S.M.A.I.O

Ref 28IW95075

Kheiron 28IW95075 is a device classified as Class IIb in the EU and Class II in the US made by S.M.A.I.O, registered in EUDAMED on 24 Jul 2023 (Basic UDI-DI B-03701313004316), cleared under FDA 510(k) K211414 on 10 Aug 2021 and listed in FDA GUDID since 16 Sep 2021 (UDI-DI 03701313004316), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211414

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701313004316 Basic UDI-DI 03701313004316UDI-DIDate24 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03701313004316 UDI-DI Date16 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211414 Date10 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03701313004316 registered 24 Jul 2023 Active
  • FDA 510(k) K211414 decided 10 Aug 2021 Active
  • FDA GUDID UDI-DI 03701313004316 listed 16 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211414
  2. Listed FDA GUDID 03701313004316
  3. Registered EUDAMED B-03701313004316

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Kheiron
Generic name
Spinal bone screw, non-bioabsorbable
Device name
Vis iliaque Ø9.5 L75mm
Model / Ref / Catalog
28IW95075
Primary DI / UDI-DI
03701313004316
Basic UDI-DI
B-03701313004316
510(k) Number
FDA product code
NKB
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3070
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K211414)

Similar devices in this category

Other devices filed under THORACOLUMBOSACRAL FIXATION SYSTEMS.

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

See all devices from S.M.A.I.O →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)