510(k) K191748
K191748 is an FDA 510(k) premarket notification submitted by Genesys Spine for the device "Genesys Spine Sacroiliac Joint Fusion System". The FDA issued a decision of Substantially Equivalent on September 26, 2019. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Genesys Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2019
- Date Received
- July 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sacroiliac Joint Fixation
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
sacroiliac joint fusion