510(k) K180729
K180729 is an FDA 510(k) premarket notification submitted by Huvexel Co. , Ltd. for the device "FaSet Fixation System". The FDA issued a decision of Substantially Equivalent on Jun 28, 2018. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Huvexel Co. , Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 2018
- Date Received
- Mar 20, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)