510(k) K250920

Arthrex Spine Compression FT Screw by Arthrex, Inc. — Product Code MRW

K250920 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Spine Compression FT Screw". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
March 27, 2025
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