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FUTS2-St

by Newclip Technics

Part of a family of 180 devices: see the family page

Ref FUTS2-ST

FUTS2-St is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 3700569600168X), cleared under FDA 510(k) K161448 on 31 Oct 2016 and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 03700569623685), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161448

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600168X Basic UDI-DI 03700569623685UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569623685 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161448 Date31 Oct 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3700569600168X registered 15 Jul 2026 Active
  • FDA 510(k) K161448 decided 31 Oct 2016 Active
  • FDA GUDID UDI-DI 03700569623685 listed 14 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161448
  2. Listed FDA GUDID 03700569623685
  3. Registered EUDAMED 3700569600168X

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  • Withdrawn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

Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plates Footmotion Plating System
Model / Ref / Catalog
FUTS2-ST
Primary DI / UDI-DI
03700569623685
Basic UDI-DI
3700569600168X
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

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 (K161448)

and 8 more cleared under K161448

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Newclip Technics

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  • QBT2.8L22-St

    Class II

See all devices from Newclip Technics →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)