510(k) K150017
K150017 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System". The FDA issued a decision of Substantially Equivalent on Apr 24, 2015. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2015
- Date Received
- Jan 5, 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
- 510(k)
sacroiliac joint fusion