Cleared Traditional

Arthrex Spine Compression FT Screw

K250920 · Arthrex, Inc. · Orthopedic
May 2025
Decision
56d
Days
—
Risk

About This 510(k) Submission

K250920 is an FDA 510(k) clearance for the Arthrex Spine Compression FT Screw, a System, Facet Screw Spinal Device, submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 22, 2025, 56 days after receiving the submission on March 27, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K250920 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2025
Decision Date May 22, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —