510(k) K110419
K110419 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS". The FDA issued a decision of Substantially Equivalent on July 28, 2011. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Stryker Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2011
- Date Received
- February 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle
- Device Class
- Class II
- Regulation Number
- 882.1350
- Review Panel
- NE
- Submission Type