Cleared Traditional

aprevo? anterior and lateral lumbar interbody fusion device, aprevo? anterior lumbar interbody fusion device with interfixation

K243802 · Carlsmed, Inc. · Orthopedic

Mar 2025

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K243802 is an FDA 510(k) clearance for the aprevo? anterior and lateral lumbar interbody fusion device, aprevo? anterior lumbar interbody fusion device with interfixation, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 17, 2025, 96 days after receiving the submission on December 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K243802 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2024
Decision Date	March 17, 2025
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.