Panels › Ear, Nose, Throat › Product code PDQ · Class 2
Neurosurgical Nerve Locator
Regulation 874.1820
2510(k)s in 12 months (36 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Nu Vasive, Incorporated | 5 | 0 |
| Spineguard S.A. | 5 | 0 |
| Alphatec Spine, Inc. | 3 | 0 |
| Magstim Company, Ltd. | 2 | 1 |
| Medos International SARL | 3 | 0 |
| Nuvasive, Inc. | 2 | 1 |
| Boston Endo Surgical Tech, | 2 | 0 |
| Neuralytix | 2 | 0 |
| Tedan Surgical Innovations | 2 | 0 |
| Biomet Spine (Aka Ebi, LLC) | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2020 | The Magstim Company Limited Neurosign V4 Intraoperative Nerve monitor family of devices. Terminated |
PDQ | K181559 |
| Jun 10, 2020 | NuVasive Inc Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery. Terminated |
PDQ | K143641 |
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