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Guided Growth Plate System 1

by Orthofix SRL 57 variants

Part of a family of 57 devices: see the family page

Ref GP400CEModel OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

Guided Growth Plate System 1 (GP400CE) is a device classified as Class IIb in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436ImpPlates2bNAC6W), cleared under FDA 510(k) K031493 on 20 Nov 2003 and listed in FDA GUDID since 10 Nov 2015 (UDI-DI 18054242513353), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031493

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436ImpPlates2bNAC6W Basic UDI-DI 18054242513353UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242513353 UDI-DI Date10 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031493 Date20 Nov 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436ImpPlates2bNAC6W registered 22 Oct 2026 Active
  • FDA 510(k) K031493 decided 20 Nov 2003 Active
  • FDA GUDID UDI-DI 18054242513353 listed 10 Nov 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031493
  2. Listed FDA GUDID 18054242513353
  3. Registered EUDAMED 805050436ImpPlates2bNAC6W

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  • Withdrawn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
Guided Growth Plate EUDAMED
Guided Growth Plate System GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS, GP400CE, 1
Primary DI / UDI-DI
18054242513353
Basic UDI-DI
805050436ImpPlates2bNAC6W
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS
GP400CE
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 18054242513353: EUDAMED states Yes, FDA GUDID states 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 fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K031493)

and 8 more cleared under K031493

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)