Cleared Traditional

aprevo? anterior and lateral lumbar interbody fusion device, aprevo? transforaminal lumbar interbody fusion device

K232282 · Carlsmed, Inc. · Orthopedic

Mar 2024

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K232282 is an FDA 510(k) clearance for the aprevo? anterior and lateral lumbar interbody fusion device, aprevo? 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 March 22, 2024, 235 days after receiving the submission on July 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232282 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2023
Decision Date	March 22, 2024
Days to Decision	235 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.