510(k) K173201
K173201 is an FDA 510(k) premarket notification submitted by Huvexel Co. , Ltd. for the device "UNITY Sacroiliac Joint Fixation System". The FDA issued a decision of Substantially Equivalent on Apr 26, 2018. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Huvexel Co. , Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 2018
- Date Received
- Oct 2, 2017
- 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