510(k) K162121
K162121 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "Siconus SI Joint Fixation System". The FDA issued a decision of Substantially Equivalent on Jan 18, 2017. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Camber Spine Technologies has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2017
- Date Received
- Aug 1, 2016
- 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