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Alians Elbow S HTDPS2D

by Newclip Technics

Part of a family of 154 devices: see the family page

Ref HTDPS2D

Alians Elbow S HTDPS2D is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics, cleared under FDA 510(k) K261191 on 8 Jul 2026, registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 3700569600028L) and listed in FDA GUDID since 14 Nov 2024 (UDI-DI 03700569660192), 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) K261191

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK261191 Date8 Jul 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number3700569600028L Basic UDI-DI 03700569660192UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569660192 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K261191 decided 8 Jul 2026 Active
  • EUDAMED Basic UDI-DI 3700569600028L registered 7 Jul 2026 Active
  • FDA GUDID UDI-DI 03700569660192 listed 14 Nov 2024 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 03700569660192
  2. Registered EUDAMED 3700569600028L
  3. Cleared FDA 510(k) K261191

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  • Withdrawn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
Alians Elbow S
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plates Alians Elbow, Plates Alians Elbow S
Model / Ref / Catalog
HTDPS2D
Primary DI / UDI-DI
03700569660192
Basic UDI-DI
3700569600028L
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
France
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 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 fixation plate, non-bioabsorbable

Cleared under the same submission (K152289)

and 8 more cleared under K152289

Cleared under the same submission (K261191)

and 8 more cleared under K261191

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Newclip Technics

  • Alians Forearm HTSIS2-ST

    Class II

  • QBT2.8L18-St

    Class II

  • QBT2.8L20-St

    Class II

  • QBT2.8L22-St

    Class II

See all devices from Newclip Technics →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)