Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators
FDA 510(k) K110419 · Stryker Spine
510(k) numberK110419
Submission
- Device name
- Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators
- Applicant
- Stryker Spine
Allendale, NJ, US - Received
- February 14, 2011
- Decision date
- July 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators cleared by the FDA?
Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators (K110419) received a 510(k) decision of Substantially Equivalent on July 28, 2011, 164 days after the submission was received.
What is the product code of K110419?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.