Cleared Traditional

WaveForm A Interbody System

K222732 · SeaSpine Orthopedics Corporation · Orthopedic

Nov 2022

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K222732 is an FDA 510(k) clearance for the 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 November 7, 2022, 59 days after receiving the submission on September 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222732 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2022
Decision Date	November 07, 2022
Days to Decision	59 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.