Leforte System Bone Plate 24-ST-006

by Jeil Medical Corporation

Leforte System Bone Plate 24-ST-006 is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K103778 on 26 Jan 2011 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 08809265154273), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

+2 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809265154273 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK103778	Date26 Jan 2011Issued	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK091679	Date2 Oct 2009Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK023360	Date25 Oct 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08809265154273
FDA 510(k) database 510(k) number K103778
FDA 510(k) database 510(k) number K091679
FDA 510(k) database 510(k) number K023360

Across registries

2 registries list this device

FDA 510(k) K103778 decided 26 Jan 2011 Active· +2 more in the status table
FDA GUDID UDI-DI 08809265154273 listed 24 Sep 2015 Listed

Timeline

4 dated events

25 Oct 2002 Cleared FDA 510(k) K023360
2 Oct 2009 Cleared FDA 510(k) K091679
26 Jan 2011 Cleared FDA 510(k) K103778
24 Sep 2015 Listed FDA GUDID 08809265154273

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Leforte System Bone Plate
Generic name: Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / reference: 24-ST-006

Primary DI / UDI-DI: 08809265154273
510(k) Number: K023360
K091679
K103778
FDA product code: JEY, KTW
GMDN term: Craniofacial fixation plate, non-bioabsorbable, non-customized

Device class: Class II
Regulation number: 872.4760, 888.3030
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Craniofacial fixation plate, non-bioabsorbable, non-customized.

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number
Manufacturing date

Other properties (9, all answered No)