Cleared Traditional

K191489 - Genesys Spine 3DP Cervical Interbody System
(FDA 510(k) Clearance)

K191489 · Genesys Spine · Orthopedic

Jan 2020

Decision

218d

Days

Class 2

Risk

K191489 is an FDA 510(k) clearance for the Genesys Spine 3DP Cervical Interbody System. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE).

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on January 8, 2020, 218 days after receiving the submission on June 4, 2019.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. 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..

Submission Details

510(k) Number	K191489 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2019
Decision Date	January 08, 2020
Days to Decision	218 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.