Navigation Instruments
Globus Navigation Instruments are reusable surgical tools used to prepare for and place spinal screws while a navigation platform relates the tools to anatomical structures. The range…
Globus Navigation Instruments are reusable surgical tools used to prepare for and place spinal screws while a navigation platform relates the tools to anatomical structures. The range includes probes, drill bits, drill guides, taps and drivers for open or minimally invasive procedures.
One configuration supports the CREO, REVERE, REVOLVE, ELLIPSE and PROTEX CT stabilization systems with the Medtronic StealthStation platform. Its manually operated stainless steel instruments work with the Synergy Spine and Trauma software, version 2.1.0.
Listed Item
4.0mm Non-Cannulated Hex Driver Shaft, GI-1 (SI-LOK)
Navigation Reference
The platform relates a rigid anatomical structure to a CT or MR model, fluoroscopy images or digitized anatomical landmarks. Instrument registration establishes the tool reference used within that navigation setup.
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K153203 |
| Record published | 2016-10-01 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Outer diameter 2.4 to 10.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6123.1226 | In distribution | |
| 6123.1065 | Outer Diameter 6.5 mm | In distribution |
| 6123.1026 | In distribution | |
| 682.940 | Outer Diameter 2.9 mm | In distribution |
| 6123.1075 | Outer Diameter 7.5 mm | In distribution |
| 6123.1235 | Outer Diameter 3.5 mm | In distribution |
| 6149.9150 | Outer Diameter 3.9 mm | In distribution |
| 6123.1414 | In distribution | |
| 6149.9126 | Outer Diameter 4.4 mm | In distribution |
| 6123.1004 | In distribution | |
| 6123.1003 | In distribution | |
| 6149.9145 | Outer Diameter 3.4 mm | In distribution |
| 6123.1619 | Outer Diameter 9.5 mm | In distribution |
| 6123.1002 | In distribution | |
| 6149.9123 | In distribution | |
| 682.920 | In distribution | |
| 6123.1206 | Outer Diameter 2.9 mm | In distribution |
| 6123.1150 | Outer Diameter 5 mm | In distribution |
| 6123.1650 | In distribution | |
| 6123.1202 | In distribution | |
| 6149.9128 | Outer Diameter 5.4 mm | In distribution |
| 6123.1020 | In distribution | |
| 6123.1240 | Outer Diameter 4 mm | In distribution |
| 682.906 | Outer Diameter 3.4 mm | In distribution |
| 6149.9141 | Outer Diameter 2.9 mm | In distribution |
| 6149.9140 | Outer Diameter 2.9 mm | In distribution |
| 6123.1204 | Outer Diameter 2.4 mm | In distribution |
| 6123.1185 | Outer Diameter 8.5 mm | In distribution |
| 6149.9200 | In distribution | |
| 6123.1155 | Outer Diameter 5.5 mm | In distribution |
| 6149.9127 | Outer Diameter 4.9 mm | In distribution |
| 6123.1617 | Outer Diameter 7.5 mm | In distribution |
| 6123.1045 | Outer Diameter 4.5 mm | In distribution |
| 6149.9155 | Outer Diameter 4.4 mm | In distribution |
| 6123.1175 | Outer Diameter 7.5 mm | In distribution |
| 6149.9125 | Outer Diameter 3.9 mm | In distribution |
| 6123.1495 | Outer Diameter 9.5 mm | In distribution |
| 6123.1165 | Outer Diameter 6.5 mm | In distribution |
| 6149.9130 | Outer Diameter 6.4 mm | In distribution |
| 6123.1101 | In distribution | |
| 6123.1008 | In distribution | |
| 6123.1405 | Outer Diameter 10.5 mm | In distribution |
| 6149.9160 | Outer Diameter 4.9 mm | In distribution |
| 6123.1618 | Outer Diameter 8.5 mm | In distribution |
| 6149.9165 | Outer Diameter 5.4 mm | In distribution |
| 682.921 | In distribution | |
| 6149.9135 | Outer Diameter 2.4 mm | In distribution |
| 6123.1225 | In distribution | |
| 682.907 | Outer Diameter 3.9 mm | In distribution |
| 6123.1620 | Outer Diameter 10.5 mm | In distribution |
| 6149.9122 | In distribution | |
| 6123.1410 | In distribution | |
| 6123.1600 | In distribution | |
| 6123.1615 | Outer Diameter 5.5 mm | In distribution |
| 6149.9129 | Outer Diameter 5.9 mm | In distribution |
| 6123.1050 | Outer Diameter 5 mm | In distribution |
| 6123.1055 | Outer Diameter 5.5 mm | In distribution |
| 6149.9124 | Outer Diameter 3.4 mm | In distribution |
| 6149.9210 | In distribution | |
| 6123.1102 | In distribution | |
| 6123.1220 | In distribution | |
| 682.935 | Outer Diameter 2.4 mm | In distribution |
| 6123.1616 | Outer Diameter 6.5 mm | In distribution |
| 6149.9136 | Outer Diameter 2.4 mm | In distribution |
| 6123.1651 | In distribution | |
| 6123.1085 | Outer Diameter 8.5 mm | In distribution |
| 6123.1406 | 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 |
|---|---|
| K250599 | 2025-11-05 |
| K243814 | 2025-01-10 |
| K243671 | 2024-12-20 |
| K240721 | 2024-06-14 |
| K240568 | 2024-04-29 |
| K233638 | 2024-02-09 |
| K211616 | 2021-08-25 |
| K200047 | 2020-07-10 |
| K191100 | 2019-07-24 |
| K190653 | 2019-04-09 |
| K180690 | 2018-06-25 |
| K171651 | 2017-08-16 |
| K153203 | 2016-02-03 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-12-15 | Class II | Device Design | Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, syste | 570 |
| 2023-12-07 | Class I | Device Design | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. | 9 |
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.