510(k) K193524
K193524 is an FDA 510(k) premarket notification submitted by SI-BONE, Inc. for the device "SI-BONE iFuse Implant System®". The FDA issued a decision of Substantially Equivalent on March 31, 2020. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. SI-BONE, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2020
- Date Received
- December 19, 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