Alara Neuro Access Needle Kit
ALARA Neuro Access Needle Kit combines a stimulating access needle, insulating sheath and extension handle. The sheath covers the needle except for the distal diamond or bevel tip, leaving…
ALARA Neuro Access Needle Kit combines a stimulating access needle, insulating sheath and extension handle. The sheath covers the needle except for the distal diamond or bevel tip, leaving that tip available for tissue stimulation.
The extension handle supports the needle during placement and creates additional working space for the surgeon. Electrical connection is provided through the separately packaged alligator-clip components included in the kit.
Listed Item
ALARA Neuro Access Needle Kit with Extension Handle- Diamond Tip
Materials and Supply
The single-use kit is supplied sterile. Needle and handle components use stainless steels and engineering polymers. Diamond-tip and bevel-tip configurations are available, with the insulating sheath defining the exposed stimulating area at the distal end.
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 | Surgentec LLC, United States |
|---|---|
| FDA product code | PDQ |
| Device type | Neurosurgical Nerve Locator |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Manufacturer |
| 510(k) | K190163 |
| Record published | 2019-07-24 |
| Record revised | 2026-05-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AAN-09-NS | In distribution | |
| AAN-09-NSW | In distribution | |
| AAN-11-NSW | In distribution | |
| AAN-11-NS | In distribution | |
| AAN-11-2NS | In distribution | |
| AAN-10-2NSW | In distribution | |
| AAN-11-NHS | In distribution | |
| AAN-09-NHS | In distribution | |
| AAN-09-2NS | In distribution | |
| AAN-09-2NSW | In distribution | |
| AAN-11-2NSW | In distribution | |
| AAN-10-2NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulse | Nuvasive, Inc. | 21 |
| Pediguard Threaded | Spineguard, SA | 19 |
| NVM5 | Nuvasive, Inc. | 15 |
| 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 |
| Boston Endo Surgical Technologies LLC | Lacey Manufacturing Company LLC | 4 |
Showing 12 of 63. All products under Neurosurgical Nerve Locator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190163 | 2019-07-16 |
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.