510(k) K183589
K183589 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "PMT Facet Screw". The FDA issued a decision of Substantially Equivalent on October 11, 2019. 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
- October 11, 2019
- Date Received
- December 21, 2018
- 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