Cleared Special

EARP Interbody System

K242457 · Retropsoas Technologies, LLC · Orthopedic

Oct 2024

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K242457 is an FDA 510(k) clearance for the EARP Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Retropsoas Technologies, LLC (Frontenac, US). The FDA issued a Cleared decision on October 7, 2024, 49 days after receiving the submission on August 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242457 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2024
Decision Date	October 07, 2024
Days to Decision	49 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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