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Leforte System Bone Screw 15-MC-010

by Jeil Medical Corporation

Ref 15-MC-010

Leforte System Bone Screw 15-MC-010 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-08809265150169), cleared under FDA 510(k) K091686 on 13 Nov 2009 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 08809265150169), 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) K091686

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809265150169 Basic UDI-DI 08809265150169UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809265150169 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091686 Date13 Nov 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809265150169 registered 28 Oct 2026 Active
  • FDA 510(k) K091686 decided 13 Nov 2009 Active
  • FDA GUDID UDI-DI 08809265150169 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091686
  2. Listed FDA GUDID 08809265150169
  3. Registered EUDAMED B-08809265150169

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  • Withdrawn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 Screw GUDID
Generic name
Craniofacial bone screw, non-bioabsorbable
Model / reference
15-MC-010
Primary DI / UDI-DI
08809265150169
Basic UDI-DI
B-08809265150169
510(k) Number
FDA product code
DZL
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4880
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 bone screw, non-bioabsorbable

Cleared under the same submission (K091686)

and 8 more cleared under K091686

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - 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)