510(k) K121551
K121551 is an FDA 510(k) premarket notification submitted by Neurostructures, LLC for the device "RESOLUTE FACET SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 23, 2012. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Neurostructures, LLC has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2012
- Date Received
- May 25, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)