CD Horizon® Solera® Voyager™ Spinal System
MAS 54750014540 4.75 EXT TAB CN 4.5X40 S
3manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| 510(k) | K143375 |
| Record published | 2016-03-16 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2020-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0114233 | DIA=7.5mm x L= 110mm | In distribution |
| 6550038 | In distribution | |
| X0114211 | DIA=7.0mm x L= 20mm | In distribution |
| X0114183 | DIA=5.0mm x L= 65mm | In distribution |
| 54750014540 | DIA= 4.5mm X L=40mm | In distribution |
| X0114237 | DIA=8.0mm x L= 35mm | In distribution |
| 1664002 | In distribution | |
| RBT036401 | In distribution | |
| X0114259 | DIA=9.0mm x L= 45mm | In distribution |
| X0114223 | DIA=7.0mm x L= 80mm | In distribution |
| X0114292 | DIA=10.0mm x L= 90mm | In distribution |
| X0114200 | DIA=6.0mm x L= 60mm | In distribution |
| X0114270 | DIA=9.0mm x L= 100mm | In distribution |
| X0114234 | DIA=8.0mm x L= 20mm | In distribution |
| X0114263 | DIA=9.0mm x L= 65mm | In distribution |
| X0114248 | DIA=8.0mm x L= 90mm | In distribution |
| 1664010 | In distribution | |
| X0114219 | DIA=7.0mm x L= 60mm | In distribution |
| X0114213 | DIA=7.0mm x L= 30mm | In distribution |
| X0114285 | DIA=9.5mm x L= 85mm | In distribution |
| X0114251 | DIA=8.0mm x L= 110mm | In distribution |
| X0114192 | DIA=6.0mm x L= 20mm | In distribution |
| X0114193 | DIA=6.0mm x L= 25mm | Withdrawn |
| X0114278 | DIA=9.5mm x L= 50mm | Withdrawn |
| X0114287 | DIA=9.5mm x L= 95mm | Withdrawn |
| X0114215 | DIA=7.0mm x L= 40mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
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.