Screwdriver, Skullplate
1.0MM/1.3MM Scrwdriver Blade FOR Raised HD Scrw/HEX CO/86MM
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | GXL |
| Device type | Screwdriver, Skullplate |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4900 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-05-09 |
| Record revised | 2024-09-19 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05.000.008 | In distribution | |
| 03.315.700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 6 |
| Surgical Instrument | Jeil Medical Corporation | 4 |
| Disposable Screwdriver Blade | Kontour (Xi’an) Medical Technology Co., Ltd. | 2 |
| Neuro Plating System | Osteonic 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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-01-30 | Class II | Labeling design | The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes i | 20081 | 2016-08-26 |
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.