Cleared Traditional

SeaSpine WaveForm C Interbody System

K212904 · SeaSpine Orthopedics Corporation · Orthopedic

Dec 2021

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K212904 is an FDA 510(k) clearance for the SeaSpine WaveForm C Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on December 14, 2021, 92 days after receiving the submission on September 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212904 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2021
Decision Date	December 14, 2021
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.