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

510(K) Number: K191489
Device Name: Genesys Spine 3DP Cervical Interbody System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 06/04/2019
Decision Date: 01/08/2020
Regulation Medical Specialty: Orthopedic

Total pages: 850
Fully redacted pages: 714
Content pages: 136