510(k) K180818
K180818 is an FDA 510(k) premarket notification submitted by Tenon Medical, Inc. for the device "Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)". The FDA issued a decision of Substantially Equivalent on June 13, 2018. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Tenon Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2018
- Date Received
- March 29, 2018
- 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