Cleared Traditional

ProAM ACDF System

K242517 · Pro Surgical, Inc. · Orthopedic

Nov 2024

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K242517 is an FDA 510(k) clearance for the ProAM ACDF System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Pro Surgical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 20, 2024, 89 days after receiving the submission on August 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242517 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2024
Decision Date	November 20, 2024
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.