Screw Head Positioner
2 catalogue numbers from F004.0002, listed by Indius Medical Technologies PVT. Ltd., India, under Positioner, Socket. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Indius Medical Technologies PVT. Ltd., India |
|---|---|
| FDA product code | KIL |
| Device type | Positioner, Socket |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F004.0002 | In distribution | |
| F004.0078 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 320 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 34 |
| Diplomat | Signus Medizintechnik Gmbh | 15 |
| Monopoly | Signus Medizintechnik Gmbh | 6 |
| Positioner, Socket | Zimmer, Inc. | 5 |
| endophix | Suzhou Endophix Co., Ltd. | 4 |
| Sterile Spine Pedicle Screw System | Wishbone Medical Inc. | 2 |
| Trilogy® | Zimmer, Inc. | 2 |
| External Fix | Smith & Nephew, Inc. | 2 |
| Positioner Guide | Abanza Tecnomed SL. | 1 |
| Cannulated Pedicle Marker | Captiva Spine, Inc. | 1 |
| Vanguard | Zimmer, Inc. | 1 |
Showing 12 of 33. All products under Positioner, Socket
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.