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The Tracker / May 2026 / K260385

510(k) cleared

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system

Carlsmed, Inc. · May 9, 2026 · K260385

FDA cleared the aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system from Carlsmed, Inc. on May 9, 2026 under K260385, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 6, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carlsmed, Inc. has 3 other decisions in the tracker over the last 12 months: K260570 (corra cervical plating system), K252894 (aprevo® cervical interbody system), K252611 (aprevo® cervical plating system).

Questions & Answers

What did FDA clear under K260385?

K260385 is the FDA 510(k) for aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system, submitted by Carlsmed, Inc.. FDA's decision date was May 9, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system?

Carlsmed, Inc., based in Carlsbad, CA, is the applicant of record for K260385.

How long did the K260385 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on May 9, 2026, 92 days later.

← All decisions in May 2026

Sources