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Aptus A-8112.80/1S

by Medartis AG

Part of a family of 1,514 devices: see the family page

Ref A-8112.80/1S

Aptus A-8112.80/1S is a device classified as Class IIb in the EU and Class II in the US made by Medartis AG, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI 76300378019PM), cleared under FDA 510(k) K232251 on 3 Nov 2023 and listed in FDA GUDID since 10 Apr 2024 (UDI-DI 07630894810442), 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) K232251

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 Number76300378019PM Basic UDI-DI 07630894810442UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630894810442 UDI-DI Date10 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232251 Date3 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300378019PM registered 22 Apr 2026 Active
  • FDA 510(k) K232251 decided 3 Nov 2023 Active
  • FDA GUDID UDI-DI 07630894810442 listed 10 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232251
  2. Listed FDA GUDID 07630894810442
  3. Registered EUDAMED 76300378019PM

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  • Withdrawn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
4.0 CCS Fully Threaded 80mm EUDAMED
Aptus GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Ccs
Model / Ref / Catalog
A-8112.80/1S
Primary DI / UDI-DI
07630894810442
Basic UDI-DI
76300378019PM
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Germany
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: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K232251)

and 8 more cleared under K232251

Similar devices in this category

Other devices filed under CANNULATED SCREWS.

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)