510(k) K251885

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant by Providence Medical Technology, Inc. — Product Code MRW

K251885 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant". The FDA issued a decision of Substantially Equivalent on July 10, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Providence Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2025
Date Received
June 20, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type