Neuro Plating System
Driver Shaft for Power Driver
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Osteonic Co., Ltd., South Korea |
|---|---|
| FDA product code | GXL |
| Device type | Screwdriver, Skullplate |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4900 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-18 |
| Record revised | 2019-06-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LDS-02 | In distribution | |
| LDS-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 6 |
| Surgical Instrument | Jeil Medical Corporation | 4 |
| Screwdriver, Skullplate | Synthes Gmbh | 2 |
| Disposable Screwdriver Blade | Kontour (Xi’an) Medical Technology Co., Ltd. | 2 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 2 |
| Hex Screwdriver Ball-End (2.5 MM) | Brainlab SE | 1 |
| ProDriver Battery Pack, Single | Pro-Dex Inc | 1 |
| Seeg Long Bolt Driver | Biomet Microfixation | 1 |
| Skull Reference Screwdriver Handle | Brainlab SE | 1 |
| Seeg Short Bolt Driver | Biomet Microfixation | 1 |
| Skull Reference Screwdriver Blade | Brainlab SE | 1 |
| Screwdriver | Neurovention, LLC | 1 |
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.