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Elos 200.1095

by Intrauma SpA

Part of a family of 13 devices: see the family page

Ref 200.1095Model 200.cef

Elos 200.1095 is a device classified as Class IIb in the EU and Class II in the US made by Intrauma SpA, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 8056693003AE), cleared under FDA 510(k) K201147 on 19 Jul 2021 and listed in FDA GUDID since 12 Sep 2022 (UDI-DI 08056693001420), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201147

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056693003AE Basic UDI-DI 08056693001420UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056693001420 UDI-DI Date12 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201147 Date19 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8056693003AE registered 26 Aug 2026 Active
  • FDA 510(k) K201147 decided 19 Jul 2021 Active
  • FDA GUDID UDI-DI 08056693001420 listed 12 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201147
  2. Listed FDA GUDID 08056693001420
  3. Registered EUDAMED 8056693003AE

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cannulated cephalic screw Ø 10,5 mm L. 95 mm EUDAMED
Elos GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Device name
ELOS - Cannulated cephalic screw
Model / Ref / Catalog
200.1095, 200.cef
Primary DI / UDI-DI
08056693001420
Basic UDI-DI
8056693003AE
510(k) Number
FDA product code
HSB
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 95 Millimeter

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: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K201147)

and 8 more cleared under K201147

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Intrauma SpA

See all devices from Intrauma SpA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)