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The Tracker / September 2026 / K262618

510(k) cleared

Arthrex Spine Compression FT Screw

Arthrex, Inc. · Sep 24, 2026 · K262618

FDA cleared the Arthrex Spine Compression FT Screw from Arthrex, Inc. on Sep 24, 2026 under K262618, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 28, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262975 (Arthrex Beaming System), K262451 (Arthrex DynaNite Staples), K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System).

Questions & Answers

What did FDA clear under K262618?

K262618 is the FDA 510(k) for Arthrex Spine Compression FT Screw, submitted by Arthrex, Inc.. FDA's decision date was Sep 24, 2026, under product code MRW (System, Facet Screw Spinal Device).

Who makes the Arthrex Spine Compression FT Screw?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K262618.

How long did the K262618 review take?

FDA received the submission on Jul 28, 2026 and issued its decision on Sep 24, 2026, 58 days later.

← All decisions in September 2026