Medtronic Resuable Instruments
Handle EX0617028 Assembly
4manufacturers in China registered for this device type
1catalogue number
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KIL |
| Device type | Positioner, Socket |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2022-11-12 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EX0617028 | 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 |
| Screw Head Positioner | Indius Medical Technologies PVT. Ltd. | 2 |
| Trilogy® | Zimmer, Inc. | 2 |
| External Fix | Smith & Nephew, Inc. | 2 |
| Positioner Guide | Abanza Tecnomed SL. | 1 |
| Cannulated Pedicle Marker | Captiva Spine, 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.