510(k) K150283
K150283 is an FDA 510(k) premarket notification submitted by Republic Spine, LLC for the device "Republic Spine Dark Star Spinal System". The FDA issued a decision of Substantially Equivalent on April 29, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Republic Spine, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2015
- Date Received
- February 5, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spondylolisthesis Spinal Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type