Pulse
Pulse Shippable Control Unit Set - ALPHA
1manufacturer
21catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Nuvasive, Inc., United States |
|---|---|
| FDA product code | PDQ |
| Device type | Neurosurgical Nerve Locator |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180038 |
| Record published | 2019-08-23 |
| Record revised | 2025-06-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5050132 | In distribution | |
| 5050120 | In distribution | |
| BETPULSELRBED | In distribution | |
| 1881000 | In distribution | |
| 5050173 | In distribution | |
| BETPULSEDRILLGUIDE | In distribution | |
| ALPPULSECART | In distribution | |
| 1840161 | In distribution | |
| BETPULSENAVINSM2 | In distribution | |
| 1802242 | In distribution | |
| BETPULSENAVINS | In distribution | |
| ALPPULSECUPM | In distribution | |
| 1833062 | In distribution | |
| PULSELRTABLET | In distribution | |
| 1801618 | In distribution | |
| 5050315 | In distribution | |
| BETPULSELRTABLET | In distribution | |
| 1801815 | In distribution | |
| BETPULSEIOMSET | In distribution | |
| 1830000 | In distribution | |
| LNPULSEIOM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K141968 | 2014-11-14 |
| K123307 | 2013-04-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Nuvasive, Inc. | 510(k) number | 2022-07-19 | Class III | Software design | Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures. | 7 |
Recalls
1 of these is Class II. 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 | Closed |
|---|---|---|---|---|---|
| 2020-06-10 | Class II | Under Investigation by firm | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. | 23 | 2021-03-22 |
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.