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Leforte System Bone Plate 16-LL-204

by Jeil Medical Corporation

Ref 16-LL-204

Leforte System Bone Plate 16-LL-204 is a device classified as Class IIb in the EU and Class II in the US made by Jeil Medical Corporation, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-08809265151326), cleared under FDA 510(k) K103778 on 26 Jan 2011 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 08809265151326), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103778

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809265151326 Basic UDI-DI 08809265151326UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809265151326 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK103778 Date26 Jan 2011IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809265151326 registered 28 Oct 2026 Active
  • FDA 510(k) K103778 decided 26 Jan 2011 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08809265151326 listed 24 Sep 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K023360
  2. Cleared FDA 510(k) K103778
  3. Listed FDA GUDID 08809265151326
  4. Registered EUDAMED B-08809265151326

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Leforte System EUDAMED
Leforte System Bone Plate GUDID
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / reference
16-LL-204
Primary DI / UDI-DI
08809265151326
Basic UDI-DI
B-08809265151326
510(k) Number
FDA product code
JEY, KTW
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4760, 888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K023360)

and 8 more cleared under K023360

Cleared under the same submission (K103778)

and 8 more cleared under K103778

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Jeil Medical Corporation

See all devices from Jeil Medical Corporation →

Properties

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