510(k) K173198
K173198 is an FDA 510(k) premarket notification submitted by U&I Corporation for the device "Facet Screw Fixation System". The FDA issued a decision of Substantially Equivalent on January 3, 2018. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. U&I Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2018
- Date Received
- October 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type