Cleared Traditional

aprevo? Cervical ACDF; aprevo? Cervical ACDF-X; aprevo? Cervical ACDF-X NO CAM

K242260 · Carlsmed, Inc. · Orthopedic
Nov 2024
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K242260 is an FDA 510(k) clearance for the aprevo? Cervical ACDF; aprevo? Cervical ACDF-X; aprevo? Cervical ACDF-X NO CAM, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 15, 2024, 107 days after receiving the submission on July 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number K242260 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2024
Decision Date November 15, 2024
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.

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