Cleared Special

ProAM ALIF System

K251644 · Pro Surgical, Inc. · Orthopedic

Jun 2025

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K251644 is an FDA 510(k) clearance for the ProAM ALIF System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Pro Surgical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 24, 2025, 26 days after receiving the submission on May 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251644 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2025
Decision Date	June 24, 2025
Days to Decision	26 days
Submission Type	Special
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.