Neuro Plating System
5 x straight plates double 2 hole 15.9mm + 5 self drilling screws Ø1.95 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
3manufacturers in China registered for this device type
55catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (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 |
| Quanzhou Apex Hygiene Products Co., Ltd. | Jinjiang | Fujian | Manufacturer | 8 |
Record
| Listed by | Osteonic Co., Ltd., South Korea |
|---|---|
| FDA product code | HBW |
| Device type | Fastener, Plate, Cranioplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5360 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K183352 |
| Record published | 2019-02-13 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NSP-002 | In distribution | |
| NSQ304X04A | In distribution | |
| NDY304M06A | In distribution | |
| NBS304S05A | In distribution | |
| NXP304M04A | In distribution | |
| NME103S00 | In distribution | |
| NBS304X05A | In distribution | |
| TCN-051 | In distribution | |
| TCN-022 | In distribution | |
| NBS304L05A | In distribution | |
| TSN-013 | In distribution | |
| NBC304M06A | In distribution | |
| NGP204S06A | In distribution | |
| NST304X02A | In distribution | |
| N18006 | In distribution | |
| N15A03 | In distribution | |
| N15A04 | In distribution | |
| NST304M10A | In distribution | |
| TSN-012 | In distribution | |
| TCN-031 | In distribution | |
| TSN-015 | In distribution | |
| NGP204L06A | In distribution | |
| NRE304M04A | In distribution | |
| NSQ304L04A | In distribution | |
| NST304M05A | In distribution | |
| NBP304M06A | In distribution | |
| NSP-004 | In distribution | |
| NDS304M06A | In distribution | |
| NBS304M05A | In distribution | |
| NST304X04A | In distribution | |
| NSQ304M04A | In distribution | |
| NSP-003 | In distribution | |
| NST304L04A | In distribution | |
| NSP-005 | In distribution | |
| N15A05 | In distribution | |
| TCN-021 | In distribution | |
| NSP-001 | In distribution | |
| NBC304L06A | In distribution | |
| NDY304L06A | In distribution | |
| NST304L02A | In distribution | |
| NGP204M06A | In distribution | |
| NME103M00 | In distribution | |
| NBP304X06A | In distribution | |
| TSN-014 | In distribution | |
| NTE204M00A | In distribution | |
| NST304M06A | In distribution | |
| NQD304M08A | In distribution | |
| N3D206M00A | In distribution | |
| NQD304L08A | In distribution | |
| NBP304S06A | In distribution | |
| NYP304M05A | In distribution | |
| NBP304L06A | In distribution | |
| N18004 | In distribution | |
| NST304M20A | In distribution | |
| TSN-016 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 1.5MM System | Biomet Microfixation | 87 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 40 |
| “2.0MM” System | Biomet Microfixation | 26 |
| Resorb XG, Sterile | KLS-Martin L.P. | 18 |
| Leforte Neuro System Bone Plate | Jeil Medical Corporation | 15 |
| CMF System | Biomet Microfixation | 14 |
| Fastener, Plate, Cranioplasty | Biomet Microfixation | 14 |
| AXS | Stryker Leibinger Gmbh & Co. KG | 14 |
| Raas Cranial Plating System | Alliance Partners, LLC | 12 |
| Thinflap System | Biomet Microfixation | 12 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 11 |
| NeuroPro® Low Profile | Kinamed, Inc. | 10 |
Showing 12 of 45. All products under Fastener, Plate, Cranioplasty
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.