Skip to content

Hinge Pediatric Plating System HPI016

by Orthopediatrics Canada ULC

Ref HPI016Model PLATE

Hinge Pediatric Plating System HPI016 is a device classified as Class IIb in the EU and Class II in the US made by Orthopediatrics Canada ULC, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 7540194HP-PLTST), cleared under FDA 510(k) K090440 on 20 May 2009 and listed in FDA GUDID since 20 Oct 2016 (UDI-DI 07540194000576), 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) K090440

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 Number7540194HP-PLTST Basic UDI-DI 07540194000576UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194000576 UDI-DI Date20 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090440 Date20 May 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7540194HP-PLTST registered 26 May 2026 Active
  • FDA 510(k) K090440 decided 20 May 2009 Active
  • FDA GUDID UDI-DI 07540194000576 listed 20 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090440
  2. Listed FDA GUDID 07540194000576
  3. Registered EUDAMED 7540194HP-PLTST

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  • Withdrawn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
The Hinge Pediatric Plating System EUDAMED
Hinge Pediatric Plating System GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Small Plate 12mm Length
Model / Ref / Catalog
HPI016, PLATE
Primary DI / UDI-DI
07540194000576
Basic UDI-DI
7540194HP-PLTST
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
Sweden
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 16 Millimeter

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

Cleared under the same submission (K090440)

and 8 more cleared under K090440

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Orthopediatrics Canada ULC

See all devices from Orthopediatrics Canada ULC →

Properties

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