GBR System Bone Plate
The FDA filing describes the GBR System as a rigid fixation system consisting of plates and screws in multiple configurations. Its intended use is to stabilize and fixate bone grafts,…
The FDA filing describes the GBR System as a rigid fixation system consisting of plates and screws in multiple configurations.
Its intended use is to stabilize and fixate bone grafts, bone-filling material, or barrier membranes used for guided bone or tissue regeneration in the oral cavity.
Plate Variants
The filing provides a catalog list of bone-plate variants and describes mesh plates for use during guided bone regeneration with dental implant surgery.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 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 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Manufacturer |
| 510(k) | K143730 |
| Record published | 2015-09-24 |
| Record revised | 2018-11-22 (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 |
|---|---|---|
| 12-GM-P02 | In distribution | |
| 12-GM-P01 | In distribution | |
| 12-GM-J01 | In distribution | |
| 12-GM-L01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252246 | 2026-04-02 |
| K150965 | 2015-09-17 |
| K143730 | 2015-06-10 |
| K103778 | 2011-01-26 |
| K091679 | 2009-10-02 |
| K050669 | 2005-05-26 |
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.