Medtronic Reusable Instruments
Instrument X0805152 6.35 MAS Head Postnr
4manufacturers in China registered for this device type
34catalogue 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 | 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 | 2022-10-11 |
| Record revised | 2026-04-29 (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 |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EX0414001 | In distribution | |
| X1202001 | In distribution | |
| EX0211234 | In distribution | |
| EX1221035 | In distribution | |
| 8616035 | In distribution | |
| EX0119013 | In distribution | |
| EX1110230 | In distribution | |
| EX0114094 | In distribution | |
| EX0418108 | In distribution | |
| X0803020 | In distribution | |
| HD6107 | In distribution | |
| EX0510284 | In distribution | |
| EX0912103 | In distribution | |
| EX0211217 | In distribution | |
| X0599050 | In distribution | |
| EX0411005 | In distribution | |
| EX0619010 | In distribution | |
| X0398-022 | In distribution | |
| EX1217016 | In distribution | |
| EX0313115 | In distribution | |
| EX0710432 | In distribution | |
| EX0418107 | In distribution | |
| EX1017002 | In distribution | |
| 80615522S | In distribution | |
| EX0411009 | In distribution | |
| EX0219037 | In distribution | |
| X0602006 | In distribution | |
| 8910641 | In distribution | |
| EX1111157 | In distribution | |
| X0602005 | In distribution | |
| EX0412215 | In distribution | |
| EX0610140 | In distribution | |
| X0805152 | In distribution | |
| X0513100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Innomed, Inc. | Innomed, Inc. | 320 |
| 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 |
| 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.