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PT4.5L54

by Newclip Technics

Part of a family of 149 devices: see the family page

Ref PT4.5L54

PT4.5L54 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 3700569600258Y), cleared under FDA 510(k) K063095 on 22 Dec 2006 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 03700569609290), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063095

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600258Y Basic UDI-DI 03700569609290UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569609290 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063095 Date22 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3700569600258Y registered 15 Jul 2026 Active
  • FDA 510(k) K063095 decided 22 Dec 2006 Active
  • FDA GUDID UDI-DI 03700569609290 listed 28 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063095
  2. Listed FDA GUDID 03700569609290
  3. Registered EUDAMED 3700569600258Y

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  • Withdrawn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 bone screw, non-bioabsorbable, non-sterile
Device name
Screws associated to the plates Alians Proximal Humerus, Activmotion S and Xpert PFP
Model / Ref / Catalog
PT4.5L54
Primary DI / UDI-DI
03700569609290
Basic UDI-DI
3700569600258Y
510(k) Number
FDA product code
HWC
EMDN code
P09120602 Cancellous screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
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 · 2 fields differ

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

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-bioabsorbable, non-sterile

Cleared under the same submission (K063095)

and 8 more cleared under K063095

Similar devices in this category

Other devices filed under CANCELLOUS SCREWS.

Other devices from Newclip Technics

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    Class II

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    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 YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)