FDA 510(k), K181295, Genesys Spine AIS-C Cervical Stand-Alone System

510(K) Number: K181295
Device Name: Genesys Spine AIS-C Cervical Stand-Alone System
Manufacturer: Genesys Spine
Device Classification Name: intervertebral fusion device with integrated fixation, cervical
Regulation Number: 888.3080
Classification Product Code: OVE
Date Received: 05/16/2018
Decision Date: 08/29/2018
Regulation Medical Specialty: Orthopedic

Total pages: 980
Fully redacted pages: 761
Content pages: 219