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Elos Instruments SE207

by Intrauma SpA

Ref SE207Model str.023

Elos Instruments SE207 is a device classified as Class I in the EU and Class II in the US made by Intrauma SpA, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 8056693186BH), cleared under FDA 510(k) K201147 on 19 Jul 2021 and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 08056693000508), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201147

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056693186BH Basic UDI-DI 08056693000508UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056693000508 UDI-DI Date20 Oct 2023ListedStatusListed 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 8056693186BH registered 26 Oct 2026 Active
  • FDA 510(k) K201147 decided 19 Jul 2021 Active
  • FDA GUDID UDI-DI 08056693000508 listed 20 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201147
  2. Listed FDA GUDID 08056693000508
  3. Registered EUDAMED 8056693186BH

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  • Withdrawn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
Strike Rod EUDAMED
Elos Instruments GUDID
Generic name
Orthopaedic implantation hammering attachment
Device name
Impaction Instruments
Model / Ref / Catalog
SE207, str.023
Primary DI / UDI-DI
08056693000508
Basic UDI-DI
8056693186BH
Direct marketing DI
08056693000508
510(k) Number
FDA product code
HSB
EMDN code
L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
GMDN term
Orthopaedic implantation hammering attachment
Device class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08056693000508: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I 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 implantation hammering attachment

Cleared under the same submission (K201147)

and 8 more cleared under K201147

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES.

Other devices from Intrauma SpA

See all devices from Intrauma SpA →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)