Cleared Traditional

aprevo? cervical interbody system

K252894 · Carlsmed, Inc. · Orthopedic
Jan 2026
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K252894 is an FDA 510(k) clearance for the aprevo? cervical interbody system, 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 January 6, 2026, 117 days after receiving the submission on September 11, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number K252894 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2025
Decision Date January 06, 2026
Days to Decision 117 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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