Dark Star Navigation
Dark Star Navigation tap is a reusable stainless steel instrument for preparation and placement of Dark Star spinal screws using Medtronic StealthStation navigation. The listed triple-lead…
Dark Star Navigation tap is a reusable stainless steel instrument for preparation and placement of Dark Star spinal screws using Medtronic StealthStation navigation. The listed triple-lead tap is one instrument within the system.
The navigation instrument family includes taps, awls, probes and drivers. It helps locate anatomical structures relative to CT, MR, fluoroscopic images or digitized landmarks during open or minimally invasive spinal procedures.
Listed Item
Dark Star Navigation Triple Lead Tap – Ø4.0mm
Compatibility
These instruments are designed for Dark Star implants and the specified StealthStation hardware and software. They are not compatible with implants from other manufacturers. The tap operates as a navigated surgical instrument rather than an implanted screw.
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 | Republic Spine, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K212028 |
| Record published | 2026-05-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Sizes | Outer diameter 4 mm |
| Distribution end date | 2026-05-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 102001-40 | Outer Diameter 4.0 mm | Withdrawn |
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 |
|---|---|
| K212028 | 2021-09-27 |
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.