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Plates Xpert Knee

by Newclip Technics SAS 19 variants

Part of a family of 56 devices: see the family page

Ref TPTGM3

Plates Xpert Knee (TPTGM3) is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics SAS, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 3700569600058S) and listed in FDA GUDID since 9 Apr 2026 (UDI-DI 03700569658717), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600058S Basic UDI-DI 03700569658717UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569658717 UDI-DI Date9 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600058S registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 03700569658717 listed 9 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569658717
  2. Registered EUDAMED 3700569600058S

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Xpert Knee
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plates Xpert Knee
Model / Ref / Catalog
TPTGM3
Primary DI / UDI-DI
03700569658717
Basic UDI-DI
3700569600058S
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 03700569658717: EUDAMED states No, FDA GUDID states Yes.

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.

Manufacturer details

EUDAMED SRN
FR-MF-000011809

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Newclip Technics SAS

See all devices from Newclip Technics SAS →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Contains latex NoEUDAMEDYesGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)