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Prct II 109-4555

by Fx Solutions

Ref 109-4555

Prct II 109-4555 is a device classified as Class IIb in the EU and Class II in the US made by Fx Solutions, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-03701037302286), cleared under FDA 510(k) K143721 on 27 Aug 2015 and listed in FDA GUDID since 6 Aug 2024 (UDI-DI 03701037302286), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K143721

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/MDD EUDAMED NumberB-03701037302286 Basic UDI-DI 03701037302286UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037302286 UDI-DI Date6 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143721 Date27 Aug 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03701037302286 registered 16 Jun 2026 Active
  • FDA 510(k) K143721 decided 27 Aug 2015 Active
  • FDA GUDID UDI-DI 03701037302286 listed 6 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143721
  2. Listed FDA GUDID 03701037302286
  3. Registered EUDAMED B-03701037302286

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Prct II
Generic name
Orthopaedic bone screw (non-sliding)
Model / reference
109-4555
Primary DI / UDI-DI
03701037302286
Basic UDI-DI
B-03701037302286
510(k) Number
FDA product code
PHX
EMDN code
P09018001 Shoulder prostheses fixing screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Legacy device (under a directive)
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 bone screw (non-sliding)

Cleared under the same submission (K143721)

and 8 more cleared under K143721

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES FIXING SCREWS.

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)