Genesys Spine

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252322SIros-X SystemOctober 22, 2025
K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemFebruary 7, 2025
K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationMarch 29, 2024
K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemDecember 13, 2023
K220096Genesys Spine 3DP Lumbar Interbody SystemMarch 9, 2022
K191489Genesys Spine 3DP Cervical Interbody SystemJanuary 8, 2020
K182987Genesys Spine 3DP Lumbar Interbody SystemDecember 12, 2019
K192678Genesys Spine Binary® Lumbar Plate SystemOctober 24, 2019
K191748Genesys Spine Sacroiliac Joint Fusion SystemSeptember 26, 2019
K192076Binary® Anterior Cervical Plate SystemAugust 29, 2019
K181295Genesys Spine AIS-C Cervical Stand-Alone SystemAugust 29, 2018
K173885Genesys Spine Binary Lumbar Plate SystemApril 3, 2018
K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemMarch 28, 2018
K172469TiLock Modular Spinal SystemNovember 30, 2017
K171838TiLock2 Spinal SystemJuly 19, 2017
K171656Genesys Spine Apache Interbody Fusion SystemJuly 13, 2017
K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemNovember 8, 2016
K161914Genesys Spine TiLock Cortical Spinal SystemAugust 9, 2016
K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemJuly 28, 2016
K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemJuly 21, 2016