Bendini
Bendini Rod Bender OCT, Spinal
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | Nuvasive, Inc., United States |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143641 |
| Record published | 2016-10-11 |
| Record revised | 2025-06-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8210300 | In distribution | |
| 8210316 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Electromyograph, Diagnostic | Medtronic Xomed, Inc. | 36 |
| Natus | Natus Neurology Incorporated | 21 |
| Natus Neurology | Natus Neurology Incorporated | 21 |
| NVM5 | Nuvasive, Inc. | 19 |
| Epad | Safeop Surgical, Inc. | 18 |
| Pulse | Nuvasive, Inc. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden Corp. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden America, Inc. | 15 |
| Natus | Xltek | 14 |
| Neuropack S3 | Nihon Kohden Corp. | 8 |
| Electromyograph, Diagnostic | Medtronic Sofamor Danek, Inc. | 7 |
| MyoVision Software | Precision Biometrics, Inc. | 5 |
Showing 12 of 49. All products under Electromyograph, Diagnostic
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 | Closed |
|---|---|---|---|---|---|---|---|
| Nuvasive, Inc. | 510(k) number | 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.