GENESYS SPINE

FDA Device Registration & Listing · Austin, TX, US · Registration 3008455034

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008455034
FEI Number
3008455034
Entity Name
GENESYS SPINE
City/State/Country
Austin, TX, US
Establishment Address
1250 S Capital of TX Highway, Building Three, Suite 600, Austin, TX 78746, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Genesys Spine (Owner Number: 10033848)
Owner / Operator Contact Address
1250 Capital of Texas Highway South, Building Three, Suite 600, Austin, TX 78746, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stasys-C Standalone 3DP TiLock Stasys-C Standalone PEEK SIros-X System Binary Anterior Cervical Plate System Apache Anchored Cervical Interbody Fusion System Genesys Spine Sacroiliac Joint Fusion System TiLock TiLock Genesys Spine Anterior Cervical Plate System Apache Interbody Fusion System TiLock Apache Interbody Fusion System Apache IBFD / VBR Apache Interbody System Apache Cervical Stand-Alone System AIS-C Stand-Alone System Genesys Spine AIS-C Cervical Stand-Alone System AIS-C Apache Genesys Spine Anterior Buttress Plate System Apache Lumbar IBFD System TiLock2 Spinal System SIros-O Sacroiliac Joint Fusion System SIros Sacroiliac Joint Fusion System with Navigation SIros-O Sacroiliac Joint Fusion System with Navigation SIros Sacroiliac Joint Fusion System TiLock Genesys Spine Rongeur TiLock Cortical Spinal System Apache Interbody Fusion System TiLock Binary Lumbar Plate System AIS-C Cervical Anchored Interbody System TiLock Binary Anterior Cervical Plate System with Helios Technology TiLock Modular Spinal System TiLock Genesys Cervical Plate with Helios Technology TiLock Genesys Cervical Plate with Helios Technology TiLock TiLock Pedicle Screw System TiLock TiLock Binary

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-05-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-11-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-11-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-11-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-05-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-05-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-17
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-12-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-11-18
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2019-12-04
HWJ Awl Orthopedic Class 1 888.4540 2010-10-12
HXB Probe Orthopedic Class 1 888.4540 2010-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-31
HWB Extractor Orthopedic Class 1 888.4540 2013-04-10
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2010-10-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2011-07-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-07-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2011-07-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-09-04
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-11-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-08-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-08-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-06-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2013-04-03
HTX Rongeur Orthopedic Class 1 888.4540 2017-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-11-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-11-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-11-18
HXL Mallet General, Plastic Surgery Class 1 878.4800 2010-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-04-06
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-04-06
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2010-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-12-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-18
HXX Screwdriver Orthopedic Class 1 888.4540 2010-10-12
HWT Template Orthopedic Class 1 888.4800 2012-11-27
HWX Tap, Bone Orthopedic Class 1 888.4540 2010-10-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-10-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-10-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-10-31
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2012-11-27
HXC Wrench Orthopedic Class 1 888.4540 2010-10-12
KTZ Caliper Orthopedic Class 1 888.4150 2015-11-05

Official Correspondent

William Sowers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Genesys Spine
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-2018 Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446 1
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008455034. Last updated year: 2026. Please use registration number 3008455034 when referencing this establishment in official correspondence.
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