Site Prep Locator – Row Series
Catalogue number SR07-6010, listed by Surgentec LLC, United States, under Neurosurgical Nerve Locator. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
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) | K240664 |
| Record published | 2025-01-03 |
| Record revised | 2026-05-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SR07-6010 | 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 |
|---|---|
| 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.