Medical Device Manufacturer · US , Austin , TX

Genesys Spine

31 submissions · 31 cleared · Since 2010
31
Total
31
Cleared
0
Denied

Genesys Spine — FDA 510(k) Submissions

Genesys Spine has submitted 31 FDA 510(k) premarket notifications since 2010, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Integrated Fixation, Cervical, Intervertebral Fusion Device With Bone Graft, Cervical . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
SIros-X System
K252322 · OUR Sacroiliac Joint Fixation · Orthopedic
Oct 2025 89d
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · OVE Intervertebral Fusion... · Orthopedic
Feb 2025 170d
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2024 142d
Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · OVE Intervertebral Fusion... · Orthopedic
Dec 2023 35d
Genesys Spine 3DP Lumbar Interbody System
K220096 · MAX Intervertebral Fusion... · Orthopedic
Mar 2022 56d
Genesys Spine 3DP Cervical Interbody System
K191489 · OVE Intervertebral Fusion... · Orthopedic
Jan 2020 218d
Genesys Spine 3DP Lumbar Interbody System
K182987 · MAX Intervertebral Fusion... · Orthopedic
Dec 2019 409d
Genesys Spine Binary? Lumbar Plate System
K192678 · KWQ Appliance, Fixation,... · Orthopedic
Oct 2019 28d
Genesys Spine Sacroiliac Joint Fusion System
K191748 · OUR Sacroiliac Joint Fixation · Orthopedic
Sep 2019 87d
Binary? Anterior Cervical Plate System
K192076 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2019 27d
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · OVE Intervertebral Fusion... · Orthopedic
Aug 2018 105d
Genesys Spine Binary Lumbar Plate System
K173885 · KWQ Appliance, Fixation,... · Orthopedic
Apr 2018 103d
Genesys Spine AIS-C Cervical Anchored Interbody System
K180056 · OVE Intervertebral Fusion... · Orthopedic
Mar 2018 79d
TiLock Modular Spinal System
K172469 · NKB Thoracolumbosacral... · Orthopedic
Nov 2017 107d
TiLock2 Spinal System
K171838 · NKB Thoracolumbosacral... · Orthopedic
Jul 2017 29d
Genesys Spine Apache Interbody Fusion System
K171656 · MAX Intervertebral Fusion... · Orthopedic
Jul 2017 38d
Genesys Spine Apache? Anterior Lumbar Interbody Fusion System
K161438 · MAX Intervertebral Fusion... · Orthopedic
Nov 2016 168d
Genesys Spine TiLock Cortical Spinal System
K161914 · NKB Thoracolumbosacral... · Orthopedic
Aug 2016 28d
Genesys Spine Apache? Anchored Cervical Interbody Fusion System
K152099 · OVE Intervertebral Fusion... · Orthopedic
Jul 2016 366d
Genesys Spine Apache? Lateral Lumbar Interbody Fusion System
K161404 · MAX Intervertebral Fusion... · Orthopedic
Jul 2016 62d
Genesys Spine Apache Interbody Fusion System
K153123 · MAX Intervertebral Fusion... · Orthopedic
Apr 2016 180d
Genesys Spine TiLock2 Spinal System
K152039 · NKB Thoracolumbosacral... · Orthopedic
Oct 2015 98d
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · ODP Intervertebral Fusion... · Orthopedic
Sep 2015 161d
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
K133245 · KWQ Appliance, Fixation,... · Orthopedic
Oct 2014 351d
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2014 254d
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