Neuromonitoring Kit
The SI-BONE Neuromonitoring Kit uses electrical stimulation to help locate and identify peripheral motor nerves and spinal nerve roots during surgery. It includes a stimulating probe, guide…
The SI-BONE Neuromonitoring Kit uses electrical stimulation to help locate and identify peripheral motor nerves and spinal nerve roots during surgery. It includes a stimulating probe, guide pin sleeve and cable electrodes in the form of a guide pin cap and clip.
The probe has a stainless steel shaft with insulation over selected areas and an exposed distal surface for tissue stimulation. A proximal connector attaches it to a monopolar stimulator.
System Use
The kit can be used with the iFuse Implant System. It is supplied sterile following ethylene oxide sterilization and is intended for single use, providing the stimulation accessories rather than a complete monitoring console.
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | SI-Bone, Inc., United States |
|---|---|
| FDA product code | PDQ |
| Device type | Neurosurgical Nerve Locator |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161893 |
| Record published | 2016-11-01 |
| Record revised | 2021-09-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -16 to 58 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400170 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulse | Nuvasive, Inc. | 21 |
| Pediguard Threaded | Spineguard, SA | 19 |
| NVM5 | Nuvasive, Inc. | 15 |
| Alara Neuro Access Needle Kit | Surgentec LLC | 12 |
| SafeOp | Alphatec Spine, Inc. | 9 |
| Sentio | Medos International Sàrl | 8 |
| TSI | Tedan Surgical Innovations, L.L.C. | 8 |
| SentioMMG | Innovative Surgical Solutions LLC | 7 |
| PediGuard DSG Connect | Spineguard, SA | 6 |
| Fresh Whole Blood Donor Transfusion Set | Safeguard US Operating, LLC | 5 |
| Arcus | Alphatec Spine, Inc. | 4 |
| Bendini | Nuvasive, Inc. | 4 |
Showing 12 of 63. All products under Neurosurgical Nerve Locator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161893 | 2016-10-18 |
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.