Cleared Traditional

WaveForm L System, WaveForm TO System, WaveForm TA System

K213420 · SeaSpine Orthopedics Corporation · Orthopedic

May 2022

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K213420 is an FDA 510(k) clearance for the WaveForm L System, WaveForm TO System, WaveForm TA 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 May 4, 2022, 196 days after receiving the submission on October 20, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K213420 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2021
Decision Date	May 04, 2022
Days to Decision	196 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.