Cleared Traditional

K250987 - aprevo? posterior/transforaminal lumbar interbody fusion device
(FDA 510(k) Clearance)

K250987 · Carlsmed, Inc. · Orthopedic

Jun 2025

Decision

91d

Days

Class 2

Risk

K250987 is an FDA 510(k) clearance for the aprevo? posterior/transforaminal lumbar interbody fusion device, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 30, 2025, 91 days after receiving the submission on March 31, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250987 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	June 30, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.