510(k) K182919
K182919 is an FDA 510(k) premarket notification submitted by Biofusion Medical for the device "SI-Restore® Sacroiliac Joint Fixation System". The FDA issued a decision of Substantially Equivalent on Jan 25, 2019. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Biofusion Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2019
- Date Received
- Oct 19, 2018
- 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
- 510(k)
sacroiliac joint fusion