K241019

aprevo® TLIF-C Articulating System

510(k) number
K241019
Device name
aprevo® TLIF-C Articulating System
Applicant
Carlsmed CA · US
Product code
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Decision date
2024-07-09
Date received
2024-04-15
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain

Also available from FDA: K241019.pdf

Official FDA record: K241019
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.