E-GPS Navigated Instrument System
The E-GPS navigated driver is a reusable manual instrument for preparing or placing compatible Precision Spine screws during spinal surgery. It works with the Globus Medical Excelsius GPS…
The E-GPS navigated driver is a reusable manual instrument for preparing or placing compatible Precision Spine screws during spinal surgery. It works with the Globus Medical Excelsius GPS Robotic Navigation Platform to help locate anatomy and guide instrument positioning.
The instrument family includes taps and drivers made from stainless steel. The instruments are supplied nonsterile and are used during open or minimally invasive procedures, with navigation based on identifiable markers and rigid anatomy in CT images or fluoroscopy.
Listed Item
Locking Polyaxial Driver, Reform Ti, Cannulated
Implant Compatibility
Use is limited to the specified Reform spinal fixation systems, including Reform Ti and the listed modular and midline cortical configurations. The navigation platform positions or orients an instrument holder or guide tube, while the driver remains the manually operated instrument used for screw placement.
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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K220862 |
| Record published | 2024-01-04 |
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 |
|---|---|---|
| 75-SD-0700 | In distribution | |
| 75-RF-1565 | In distribution | |
| 75-RF-1595 | In distribution | |
| 75-RF-1575 | In distribution | |
| 75-RT-1800 | In distribution | |
| 75-RF-1585 | In distribution | |
| 75-RT-1700 | In distribution | |
| 75-RT-1750 | In distribution | |
| 75-RF-1555 | 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 |
|---|---|
| K231229 | 2023-05-25 |
| K220862 | 2022-07-14 |
| K181606 | 2019-09-27 |
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.