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Leforte System Bone Plate 242.51LR04.01

by Jeil Medical Corporation

Ref 242.51LR04.01

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Overview

The Leforte System Bone Plate is a non-customized, implantable craniofacial fixation plate made of non-bioabsorbable materials. It is designed to bridge and stabilize fractures in the cranium and facial bones, and is available for use as an implantable medical device.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806390802253 Basic UDI-DI 08806390802253UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806390802253 UDI-DI Date23 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Leforte System EUDAMED
Leforte System Bone Plate GUDID
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Reference
242.51LR04.01
Primary DI / UDI-DI
08806390802253
Basic UDI-DI
B-08806390802253
510(k) Number
FDA Product Code
JEY
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
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

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

Cleared under the same submission (K150965)

Show all (12)

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No