510(k) K170800
K170800 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive LessRay with Enhanced Tracking". The FDA issued a decision of Substantially Equivalent on Aug 18, 2017. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Nu Vasive, Incorporated has 111 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2017
- Date Received
- Mar 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
- 510(k)
Interventional fluoroscopy