Cleared Traditional

Meridian Interbody System; WaveForm A Interbody System

K233694 · SeaSpine Orthopedics Corporation · Orthopedic

Jan 2024

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K233694 is an FDA 510(k) clearance for the Meridian Interbody System; WaveForm A Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on January 12, 2024, 56 days after receiving the submission on November 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K233694 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2023
Decision Date	January 12, 2024
Days to Decision	56 days
Submission Type	Traditional
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.