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Leforte Neuro System Bone Plate

by Jeil Medical Corporation

510(k) K112812

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 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08806390805070 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK112812 Date22 Feb 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Reference
NS-3MA-200-04
Primary DI / UDI-DI
08806390805070
510(k) Number
FDA Product Code
GWO, JEY, HBW, GXR
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Class
Class II
Regulation
21 CFR Part 882.5320 510(k)GUDID
21 CFR Part 872.4760 510(k)GUDID
882.5360 GUDID
882.5250 GUDID
Advisory Committee
Neurology
Dental
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Leforte Neuro System Bone Plate is a bone fixation device classified as a Plate, Bone under FDA nomenclature. It is designed to stabilize and support bone segments in the maxillofacial region, particularly for reconstructive procedures involving the midface, including Leforte I and II fractures. Constructed to provide rigid internal fixation, it aids in the alignment and healing of complex facial bone injuries.

This device is supplied as a sterile, single-use product intended for use in operating room settings by trained surgeons. It is regulated under FDA 510(k) clearance (K103778) as a Class II medical device under regulation number 872.4760, with multiple FEI numbers corresponding to various plate sizes and configurations. Storage requires adherence to sterile packaging instructions, and its use is restricted to qualified healthcare professionals in controlled surgical environments.

Other devices from Jeil Medical Corporation

See all devices from Jeil Medical Corporation →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of facial bone injuries is the Leforte Neuro System Bone Plate specifically designed to address in reconstructive procedures?

    The Leforte Neuro System Bone Plate is designed to stabilize and support bone segments in the midface region, particularly for reconstructive procedures involving Leforte I and II fractures. These types of fractures involve the maxilla and zygomatic bones, and the plate provides rigid internal fixation to aid in proper alignment and healing of complex facial bone injuries.

  • Is the Leforte Neuro System Bone Plate intended for reuse, or is it meant to be used only once per patient?

    The Leforte Neuro System Bone Plate is explicitly supplied as a sterile, single-use product. This ensures patient safety and sterility in operating room settings, where it is intended to be used only once before disposal.

  • How should the Leforte Neuro System Bone Plate be stored to maintain its sterility and integrity?

    The device must be stored strictly according to the sterile packaging instructions provided by Jeil Medical Corporation. Since it is a single-use, sterile product, it should remain unopened and protected from contamination until use in a controlled surgical environment.

  • What regulatory pathway was followed for FDA clearance of the Leforte Neuro System Bone Plate, and what classification does it hold?

    The Leforte Neuro System Bone Plate received FDA 510(k) clearance under the classification of a Class II medical device (regulation number 872.4760). The clearance was granted as substantially equivalent to a predicate device, with a special clearance type and a dental advisory committee review.

  • Are there multiple sizes or configurations available for the Leforte Neuro System Bone Plate, and how are they differentiated?

    Yes, the Leforte Neuro System Bone Plate comes in multiple sizes and configurations, each corresponding to a unique FDA Establishment Inspection Report (FEI) number. These variations allow for tailored use in different midface reconstruction scenarios, ensuring proper fit and fixation for Leforte I and II fractures.

Properties

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

Other properties (9)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No