Cleared Traditional

aprevo? anterior lumbar interbody fusion device with interfixation

K222009 · Carlsmed, Inc. · Orthopedic

Nov 2022

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K222009 is an FDA 510(k) clearance for the aprevo? anterior lumbar interbody fusion device with interfixation, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2022, 138 days after receiving the submission on July 7, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222009 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2022
Decision Date	November 22, 2022
Days to Decision	138 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.