Genesys Spine

FDA Filings

This page includes the latest FDA filings for Genesys Spine. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008455034
• FEI Number: 3008455034
• Name: GENESYS SPINE
• Owner & Operator: Genesys Spine
• Contact Address: 1250 Capital of Texas Highway South Building Three, Suite 600; Austin TX 78746 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1250 S Capital of TX Highway Building Three, Suite 600; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K220096 Genesys Spine	Genesys Spine 3DP Lumbar Interbody System	2022-03-09
PMN K191489 Genesys Spine	Genesys Spine 3DP Cervical Interbody System	2020-01-08
PMN K182987 | MAX GENESYS SPINE	Genesys Spine 3DP Lumbar Interbody System	2020-01-02
PMN K182987 Genesys Spine	Genesys Spine 3DP Lumbar Interbody System	2019-12-12
PMN K192678 | KWQ GENESYS SPINE	Genesys Spine Binary? Lumbar Plate System	2019-12-04
PMN K192076 | KWQ GENESYS SPINE	Binary Anterior Cervical Plate System	2019-12-04
PMN K191748 | OUR GENESYS SPINE	Genesys Spine Sacroiliac Joint Fusion System	2019-12-04
PMN K192678 Genesys Spine	Genesys Spine Binary® Lumbar Plate System	2019-10-24
PMN K191748 Genesys Spine	Genesys Spine Sacroiliac Joint Fusion System	2019-09-26
PMN K192076 Genesys Spine	Binary® Anterior Cervical Plate System	2019-08-29
PMN K181295 | OVE GENESYS SPINE	Genesys Spine AIS-C Cervical Stand-Alone System	2018-09-04
PMN K181295 | OVE GENESYS SPINE	Apache Cervical Stand-Alone System	2018-09-04
PMN K181295 | OVE GENESYS SPINE	AIS-C	2018-09-04
PMN K181295 | OVE GENESYS SPINE	AIS-C Stand-Alone System	2018-09-04
PMN K181295 Genesys Spine	Genesys Spine AIS-C Cervical Stand-Alone System	2018-08-29
PMN K180056 | OVE GENESYS SPINE	AIS-C Cervical Anchored Interbody System	2018-04-06
PMN K173885 | KWQ GENESYS SPINE	Binary Lumbar Plate System	2018-04-06
PMN K173885 Genesys Spine	Genesys Spine Binary Lumbar Plate System	2018-04-03
PMN K180056 Genesys Spine	Genesys Spine AIS-C Cervical Anchored Interbody System	2018-03-28
PMN K172469 | NKB GENESYS SPINE	TiLock Modular Spinal System	2017-12-18
PMN K172469 | KWQ GENESYS SPINE	TiLock Modular Spinal System	2017-12-18
PMN K172469 | KWP GENESYS SPINE	TiLock Modular Spinal System	2017-12-18
HTX GENESYS SPINE	Genesys Spine Rongeur	2017-12-18
PMN K172469 Genesys Spine	TiLock Modular Spinal System	2017-11-30
PMN K171838 | NKB GENESYS SPINE	TiLock2 Spinal System	2017-08-24
PMN K171838 | KWP GENESYS SPINE	TiLock2 Spinal System	2017-08-24
PMN K171656 | MAX GENESYS SPINE	Apache Milled Titanium IBFD	2017-08-24
PMN K171838 Genesys Spine	TiLock2 Spinal System	2017-07-19
PMN K171656 Genesys Spine	Genesys Spine Apache Interbody Fusion System	2017-07-13
PMN K161914 | NKB GENESYS SPINE	TiLock Cortical Spinal System	2016-11-18
PMN K161914 | MNI GENESYS SPINE	TiLock Cortical Spinal System	2016-11-18
PMN K161914 | MNH GENESYS SPINE	TiLock Cortical Spinal System	2016-11-18
PMN K161438 | MAX GENESYS SPINE	Apache Hyperlordotic ALIF	2016-11-18
PMN K161404 | MAX GENESYS SPINE	Apache Lateral Lumbar IBFD System	2016-11-18
PMN K153123 | MAX GENESYS SPINE	Apache Lumbar IBFD System	2016-11-18
PMN K152099 | OVE GENESYS SPINE	Apache Anchored Cervical Interbody Fusion System	2016-11-18
PMN K161438 GENESYS SPINE	Genesys Spine Apache® Anterior Lumbar Interbody Fusion System	2016-11-08
PMN K161914 Genesys Spine	Genesys Spine TiLock Cortical Spinal System	2016-08-09
PMN K152099 GENESYS SPINE	Genesys Spine Apache® Anchored Cervical Interbody Fusion System	2016-07-28
PMN K161404 Genesys Spine	Genesys Spine Apache® Lateral Lumbar Interbody Fusion System	2016-07-21
PMN K153123 GENESYS SPINE	Genesys Spine Apache Interbody Fusion System	2016-04-26
PMN K152039 | NKB GENESYS SPINE	TiLock	2015-11-05
PMN K152039 | MNI GENESYS SPINE	TiLock	2015-11-05
PMN K152039 | MNH GENESYS SPINE	TiLock	2015-11-05
PMN K150812 | ODP GENESYS SPINE	Apache	2015-11-05
KTZ GENESYS SPINE	Binary	2015-11-05
PMN K152039 Genesys Spine	Genesys Spine TiLock2 Spinal System	2015-10-28
PMN K150812 Genesys Spine	Genesys Spine Apache Cervical Interbody Fusion System	2015-09-03
PMN K133911 | KWQ GENESYS SPINE	Genesys Spine Anterior Buttress Plate System	2014-12-29
PMN K133245 | KWQ GENESYS SPINE	Binary Anterior Cervical Plate System with Helios Technology	2014-12-29
PMN K133245 GENESYS SPINE	GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM	2014-10-08
PMN K133911 GENESYS SPINE	GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM	2014-09-03
PMN K130913 | MAX GENESYS SPINE	Apache Lateral Lumbar Interbody Fusion System	2013-12-20
PMN K130317 | ODP GENESYS SPINE	Apache IBFD Star Cervical System	2013-12-20
PMN K130913 GENESYS SPINE	GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM	2013-12-13
PMN K130317 GENESYS SPINE	GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM	2013-12-11
HWB GENESYS SPINE	Apache Interbody Fusion System	2013-04-10
HXI GENESYS SPINE	TiLock	2013-04-03
HXZ GENESYS SPINE	TiLock	2012-11-27
HWT GENESYS SPINE	TiLock	2012-11-27
PMN K111132 | KWQ GENESYS SPINE	Genesys Spine Anterior Cervical Plate System	2012-01-31
PMN K111132 GENESYS SPINE	GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM	2011-12-09
PMN K103671 | NKB GENESYS SPINE	TiLock Pedicle Screw System	2011-10-31
PMN K103671 | MNI GENESYS SPINE	TiLock Pedicle Screw System	2011-10-31
PMN K103671 | MNH GENESYS SPINE	TiLock Pedicle Screw System	2011-10-31
PMN K103671 GENESYS SPINE	GENESYS SPINE TILOCK SYSTEM	2011-07-21
PMN K103034 | ODP GENESYS SPINE	Apache Interbody System	2011-07-18
PMN K103034 | ODP GENESYS SPINE	Apache IBFD / VBR	2011-07-18
PMN K103034 | MQP GENESYS SPINE	Apache Interbody System	2011-07-18
PMN K103034 | MQP GENESYS SPINE	Apache IBFD / VBR	2011-07-18
PMN K103034 | MAX GENESYS SPINE	Apache Interbody System	2011-07-18
PMN K103034 | MAX GENESYS SPINE	Apache IBFD / VBR	2011-07-18
PMN K103034 GENESYS SPINE	GENESYS SPINE INTERBODY FUSION SYSTEM	2010-12-10
PMN K100757 | NKB GENESYS SPINE	TiLock Pedicle Screw System	2010-10-12
PMN K100757 | NKB GENESYS SPINE	Luna 360	2010-10-12
PMN K100757 | MNI GENESYS SPINE	TiLock Pedicle Screw System	2010-10-12
PMN K100757 | MNI GENESYS SPINE	Luna 360	2010-10-12
PMN K100757 | MNH GENESYS SPINE	TiLock Pedicle Screw System	2010-10-12
PMN K100757 | MNH GENESYS SPINE	Luna 360	2010-10-12
LXH GENESYS SPINE	TiLock	2010-10-12
LXH GENESYS SPINE	Apache Interbody Fusion System	2010-10-12
HXX GENESYS SPINE	TiLock	2010-10-12
HXX GENESYS SPINE	Genesys Cervical Plate with Helios Technology	2010-10-12
HXW GENESYS SPINE	TiLock	2010-10-12
HXW GENESYS SPINE	Genesys Cervical Plate with Helios Technology	2010-10-12
HXL GENESYS SPINE	TiLock	2010-10-12
HXL GENESYS SPINE	Apache Interbody Fusion System	2010-10-12
HXC GENESYS SPINE	TiLock	2010-10-12
HXB GENESYS SPINE	TiLock	2010-10-12
HWX GENESYS SPINE	TiLock	2010-10-12
HWX GENESYS SPINE	Genesys Cervical Plate with Helios Technology	2010-10-12
HWJ GENESYS SPINE	TiLock	2010-10-12
HTC GENESYS SPINE	TiLock	2010-10-12
PMN K100757 GENESYS SPINE	TILOCK PEDICLE SCREW SYSTEM	2010-07-01