510(k) K203373
K203373 is an FDA 510(k) premarket notification submitted by Advanced Research Medical, LLC for the device "Advanced Research Medical Trident SI Screw System". The FDA issued a decision of Substantially Equivalent on January 22, 2021. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Advanced Research Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2021
- Date Received
- November 16, 2020
- 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