OsteoMed
1.6MM Driver Stem W/Post, AO Shnk, Short
2manufacturers in China registered for this device type
6catalogue 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 | Osteomed, United States |
|---|---|
| FDA product code | GXL |
| Device type | Screwdriver, Skullplate |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4900 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-10-26 |
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 |
| Sizes | Length 1.88 to 3.66 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 114-2052 | Length 3.66 in | In distribution |
| 114-2051 | Length 2.5 in | In distribution |
| 114-1652 | Length 3.66 in | In distribution |
| 114-1651 | Length 2.5 in | In distribution |
| 114-1650 | Length 1.88 in | In distribution |
| 114-2050 | Length 1.88 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Instrument | Jeil Medical Corporation | 4 |
| Screwdriver, Skullplate | Synthes Gmbh | 2 |
| 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 |
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.