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Aptus A-2005

by Medartis AG 2 variants

Part of a family of 18 devices: see the family page

Ref A-2005

Aptus A-2005 is a device classified as Class I in the EU and Class II in the US made by Medartis AG, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 76300378010P3), cleared under FDA 510(k) K193639 on 26 Mar 2020 and listed in FDA GUDID since 24 Feb 2023 (UDI-DI 07630037872825), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193639

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378010P3 Basic UDI-DI 07630037872825UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037872825 UDI-DI Date24 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193639 Date26 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300378010P3 registered 13 Apr 2026 Active
  • FDA 510(k) K193639 decided 26 Mar 2020 Active
  • FDA GUDID UDI-DI 07630037872825 listed 24 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193639
  2. Listed FDA GUDID 07630037872825
  3. Registered EUDAMED 76300378010P3

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  • Withdrawn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
2.8/3.5 Wedge Inserter EUDAMED
Aptus GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Plate holding & positioning Instruments
Model / Ref / Catalog
A-2005
Primary DI / UDI-DI
07630037872825
Basic UDI-DI
76300378010P3
510(k) Number
FDA product code
HRS
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Germany
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 I
GUDID
Class II

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: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K193639)

and 8 more cleared under K193639

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)