Medyssey Navigation Instrument
This reusable Medyssey screw driver is used during preparation and placement of Medyssey screws in spinal surgery. With the Medtronic StealthStation navigation system and its NavLock…
This reusable Medyssey screw driver is used during preparation and placement of Medyssey screws in spinal surgery. With the Medtronic StealthStation navigation system and its NavLock arrays, the instruments help the surgeon locate anatomy during open or minimally invasive procedures.
The instruments are made of medical-grade stainless steel and supplied clean but nonsterile for user sterilization. Their use is limited to specified Medyssey spinal fixation systems, including ARTeMIS.
Listed Item
ARTeMIS Navigation Screw driver
Compatible Systems
Use is limited to the ILIAD and Zenius fixation systems, with Zenius including Hedjet and ARTeMIS screw systems. The navigation platform provides the location reference used during these procedures.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medyssey Co., Ltd., South Korea |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K242806 |
| Record published | 2025-02-11 |
| Record revised | 2025-07-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SNCDT-R45N | In distribution | |
| SNCDT-R55N | In distribution | |
| SNCTM-R55N | In distribution | |
| SNXTS-S55N | In distribution | |
| SNCTM-R45N | In distribution | |
| SNXTS-S75N | In distribution | |
| SNXTS-S45N | In distribution | |
| SNCDT-R75N | In distribution | |
| SNXTS-S65N | In distribution | |
| SNXPD-N01 | In distribution | |
| SNCTM-R75N | In distribution | |
| SNCDT-R65N | In distribution | |
| SNCTM-R65N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242806 | 2025-04-16 |
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.