Leforte Neuro System Bone Plate
Leforte Neuro System Bone Plate is part of a plate-and-screw system for selected cranial trauma, cranial surgery and reconstruction. Plates in different shapes and sizes are secured to bone…
Leforte Neuro System Bone Plate is part of a plate-and-screw system for selected cranial trauma, cranial surgery and reconstruction. Plates in different shapes and sizes are secured to bone with screws, with convenience kits and procedural accessories also available.
Plates use commercially pure titanium and have an anodized surface. The system’s screws use Ti-6Al-4V ELI titanium alloy. Plate thicknesses range from 0.3 to 1.0 mm.
Preparation and Use
The plates and screws are single-use implants supplied nonsterile. They require steam sterilization by the user before surgery. Available screw diameters range from 1.4 to 1.8 mm, allowing selection with the appropriate plate and operative requirements.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
Record
| Listed by | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | GWO |
| Device type | Plate, Cranioplasty, Preformed, Alterable |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5320 |
| Establishment | Manufacturer |
| 510(k) | K141452 |
| Record published | 2015-09-24 |
| Record revised | 2018-11-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL-DY-106 | In distribution | |
| NL-BR-040 | In distribution | |
| NL-GP-020 | In distribution | |
| NL-3MD-060-03 | In distribution | |
| NL-ST-104 | In distribution | |
| NS-3MD-100-06R | In distribution | |
| N16-TM-010S | In distribution | |
| N16-QD-006 | In distribution | |
| N16-TM-020S | In distribution | |
| NL-SQ-104 | In distribution | |
| N16-BR-012S | In distribution | |
| NL-BR-041 | In distribution | |
| NL-ST-102 | In distribution | |
| N16-MM-010S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 103 |
| Plate, Cranioplasty, Preformed, Alterable | Stryker Leibinger Gmbh & Co. KG | 93 |
| 1.5MM System | Biomet Microfixation | 72 |
| Customized Skull Implant (CSI) | Kelyniam Global Inc. | 49 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 35 |
| 2.0MM System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 26 |
| Plate, Cranioplasty, Preformed, Alterable | Biomet Microfixation | 22 |
| Innovasis® Cranial System | Inno-Health Technology Co., Ltd. | 21 |
| NeuroPro® Low Profile | Kinamed, Inc. | 16 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
Showing 12 of 45. All products under Plate, Cranioplasty, Preformed, Alterable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170368 | 2017-09-11 |
| K141452 | 2014-07-02 |
| K112812 | 2012-02-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.