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Aptus A-4856.10

by Medartis Inc.

Ref A-4856.10

Aptus A-4856.10 is a device classified as Class IIb in the EU and Class II in the US made by Medartis Inc., registered in EUDAMED on 25 Mar 2025 (Basic UDI-DI 76300378020P6), cleared under FDA 510(k) K103332 on 24 Jan 2011 and listed in FDA GUDID since 24 Feb 2023 (UDI-DI 07630037895480), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103332

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378020P6 Basic UDI-DI 07630037895480UDI-DIDate25 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037895480 UDI-DI Date24 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103332 Date24 Jan 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76300378020P6 registered 25 Mar 2025 Active
  • FDA 510(k) K103332 decided 24 Jan 2011 Active
  • FDA GUDID UDI-DI 07630037895480 listed 24 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103332
  2. Listed FDA GUDID 07630037895480
  3. Registered EUDAMED 76300378020P6

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  • Withdrawn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 TriLock Olecranon Plate, 7H, Right EUDAMED
Aptus GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device name
Bone plates (sterile, non-sterile)
Model / Ref / Catalog
A-4856.10
Primary DI / UDI-DI
07630037895480
Basic UDI-DI
76300378020P6
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class IIb 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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K103332)

and 8 more cleared under K103332

Other devices from Medartis Inc.

  • Avenger M70HC018

    Class II

  • Avenger M70HC020

    Class II

  • Avenger M70HC022

    Class II

  • Avenger M70HC024

    Class II

See all devices from Medartis Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)