510(k) K151462
K151462 is an FDA 510(k) premarket notification submitted by Si-Technology, LLC for the device "SI-TECHNOLOGY® SI-DESIS® SCREWS". The FDA issued a decision of Substantially Equivalent on Aug 12, 2015. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Si-Technology, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2015
- Date Received
- Jun 1, 2015
- 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