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Juniortho Plating System 1

by Orthofix SRL 352 variants

Part of a family of 71 devices: see the family page

Ref 5434002LModel OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

Juniortho Plating System 1 (5434002L) is an orthopaedic fixation plate (EU MDR Class IIb; FDA Class II; FDA product code HRS, Plate, Fixation, Bone) made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436NStePlate2bN27ET), cleared under FDA 510(k) K200246 on 22 May 2020 and listed in FDA GUDID since 1 Jul 2020 (UDI-DI 18053800899007), 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) K200246

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 Number805050436NStePlate2bN27ET Basic UDI-DI 18053800899007UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18053800899007 UDI-DI Date1 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200246 Date22 May 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436NStePlate2bN27ET registered 22 Oct 2026 Active
  • FDA 510(k) K200246 decided 22 May 2020 Active
  • FDA GUDID UDI-DI 18053800899007 listed 1 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200246
  2. Listed FDA GUDID 18053800899007
  3. Registered EUDAMED 805050436NStePlate2bN27ET

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  • Withdrawn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
JPS JuniOrtho Plating System EUDAMED
Juniortho Plating System GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS, 5434002L, 1
Primary DI / UDI-DI
18053800899007
Basic UDI-DI
805050436NStePlate2bN27ET
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
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
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 207 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
OSTEOSYNTHESIS SCREW-PLATE SYSTEMS
5434002L
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Sterilise before use UDI-DI 18053800899007: 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.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K200246)

and 8 more cleared under K200246

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 NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)