510(k) K230840
K230840 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "PMT Facet Fixation System, Lumbar (PMT FFS-LX)". The FDA issued a decision of Substantially Equivalent on December 19, 2023. 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
- December 19, 2023
- Date Received
- March 27, 2023
- Clearance Type
- Traditional
- 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