510(k) K213815
K213815 is an FDA 510(k) premarket notification submitted by Vgi Medical, Inc. for the device "SiJoin®T3". The FDA issued a decision of Substantially Equivalent on March 29, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2023
- Date Received
- December 7, 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
sacroiliac joint fusion