The following data is part of a premarket notification filed by Stryker Spine with the FDA for Avs Aria Neuromonitoring Probe And Avs Aria Probe Dilators.
| Device ID | K110419 |
| 510k Number | K110419 |
| Device Name: | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS |
| Classification | Electrode, Needle |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Tiffani D Rogers |
| Correspondent | Tiffani D Rogers STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-07-28 |
| Summary: | summary |