510(k) K161798
K161798 is an FDA 510(k) premarket notification submitted by Ldr Spine USA, Inc. for the device "FacetBRIDGE® System". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Ldr Spine USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2016
- Date Received
- June 30, 2016
- Clearance Type
- Special
- 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