Cleared Traditional

aprevo? Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo? Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo? Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

K241328 · Carlsmed, Inc. · Orthopedic

Aug 2024

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K241328 is an FDA 510(k) clearance for the aprevo? Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo? Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo? Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X), 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 August 12, 2024, 94 days after receiving the submission on May 10, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K241328 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2024
Decision Date	August 12, 2024
Days to Decision	94 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.