K241328

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)

510(k) number: K241328
Device name: 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)
Applicant: Carlsmed, Inc. CA · US
Product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Decision date: 2024-08-12
Date received: 2024-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K241328.pdf

Official FDA record: K241328

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.