510(k) K132126
K132126 is an FDA 510(k) premarket notification submitted by Spectrum Spine, LLC for the device "SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 2013. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Spectrum Spine, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2013
- Date Received
- July 10, 2013
- 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