Medical Device Manufacturer · US , Austin , TX

Genesys Spine - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2010

Recent clearances: SIros-X System, Genesys Spine AIS-C II Cervical Interbody Fusion System, Genesys Spine Sacroiliac Joint Fusion System with Navigation

31
Total
31
Cleared
0
Denied

FDA 510(k) Regulatory Record - Genesys Spine Orthopedic ✕

31 devices
1-12 of 31
Cleared Oct 22, 2025
SIros-X System
K252322 · OUR
Orthopedic · 89d
Cleared Feb 07, 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · OVE
Orthopedic · 170d
Cleared Mar 29, 2024
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · OLO
Orthopedic · 142d
Cleared Dec 13, 2023
Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · OVE
Orthopedic · 35d
Cleared Mar 09, 2022
Genesys Spine 3DP Lumbar Interbody System
K220096 · MAX
Orthopedic · 56d
Cleared Jan 08, 2020
Genesys Spine 3DP Cervical Interbody System
K191489 · OVE
Orthopedic · 218d
Cleared Dec 12, 2019
Genesys Spine 3DP Lumbar Interbody System
K182987 · MAX
Orthopedic · 409d
Cleared Oct 24, 2019
Genesys Spine Binary® Lumbar Plate System
K192678 · KWQ
Orthopedic · 28d
Cleared Sep 26, 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · OUR
Orthopedic · 87d
Cleared Aug 29, 2019
Binary® Anterior Cervical Plate System
K192076 · KWQ
Orthopedic · 27d
Cleared Aug 29, 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · OVE
Orthopedic · 105d
Cleared Apr 03, 2018
Genesys Spine Binary Lumbar Plate System
K173885 · KWQ
Orthopedic · 103d
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