510(k) K163374
K163374 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "ALLY Facet Screws". The FDA issued a decision of Substantially Equivalent on February 16, 2017. 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
- February 16, 2017
- Date Received
- December 1, 2016
- 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