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Elos 200.0001

by Intrauma SpA

Ref 200.0001Model 200.cap

Elos 200.0001 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 8056693002AC), cleared under FDA 510(k) K201147 on 19 Jul 2021 and listed in FDA GUDID since 12 Sep 2022 (UDI-DI 08056693001352), active as of 23 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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056693002AC Basic UDI-DI 08056693001352UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056693001352 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 8056693002AC registered 26 Aug 2026 Active
  • FDA 510(k) K201147 decided 19 Jul 2021 Active
  • FDA GUDID UDI-DI 08056693001352 listed 12 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201147
  2. Listed FDA GUDID 08056693001352
  3. Registered EUDAMED 8056693002AC

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  • Withdrawn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
ELOS - Nail cap EUDAMED
Elos GUDID
Generic name
Bone nail implantable cap
Model / Ref / Catalog
200.0001, 200.cap
Primary DI / UDI-DI
08056693001352
Basic UDI-DI
8056693002AC
510(k) Number
FDA product code
HSB
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone nail implantable cap
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

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: Bone nail end-cap

Cleared under the same submission (K201147)

and 8 more cleared under K201147

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

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)