510(k) K213590
K213590 is an FDA 510(k) premarket notification submitted by Osseus Fusion Systems, LLC for the device "Blue Topaz Sacroiliac Screw System". The FDA issued a decision of Substantially Equivalent on Mar 1, 2022. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Osseus Fusion Systems, LLC has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2022
- Date Received
- Nov 12, 2021
- 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