Cleared Traditional

aprevo? anterior lumbar interbody fusion device; aprevo? lateral lumbar interbody fusion device; aprevo? anterior lumbar interbody fusion device with interfixation; aprevo? transforaminal lumbar interbody fusion device; aprevo? TLIF-CA Articulating System; aprevo? Cervical ACDF; aprevo? Cervical ACDF-X; aprevo? Cervical ACDF-X No Cams

K250827 · Carlsmed, Inc. · Orthopedic

Jul 2025

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K250827 is an FDA 510(k) clearance for the aprevo? anterior lumbar interbody fusion device; aprevo? lateral lumbar interbody fusion device; aprevo? anterior lumbar interbody fusion device with interfixation; aprevo? transforaminal lumbar interbody fusion device; aprevo? TLIF-CA Articulating System; aprevo? Cervical ACDF; aprevo? Cervical ACDF-X; aprevo? Cervical ACDF-X No Cams, 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 July 7, 2025, 111 days after receiving the submission on March 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250827 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2025
Decision Date	July 07, 2025
Days to Decision	111 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.