510(k) K211785
K211785 is an FDA 510(k) premarket notification submitted by Ctl Medical Corporation for the device "CASSATT SIJ Fixation System". The FDA issued a decision of Substantially Equivalent on Oct 17, 2022. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Ctl Medical Corporation has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2022
- Date Received
- Jun 9, 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