Genesys Spine 3DP Cervical Interbody System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Genesys Spine

The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine 3dp Cervical Interbody System.

Pre-market Notification Details

• Device ID: K191489
• 510k Number: K191489
• Device Name: Genesys Spine 3DP Cervical Interbody System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746
• Contact: Benjamin V. Keller
• Correspondent: Benjamin V. Keller; Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-04
• Decision Date: 2020-01-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M719GC3THL120	K191489	000
M719GC3THSL060	K191489	000
M719GC3THSL06SD0	K191489	000
M719GC3THSL070	K191489	000
M719GC3THSL07SD0	K191489	000
M719GC3THSL080	K191489	000
M719GC3THSL08SD0	K191489	000
M719GC3THSL090	K191489	000
M719GC3THSL09SD0	K191489	000
M719GC3THSL100	K191489	000
M719GC3THSL05SD0	K191489	000
M719GC3THSL050	K191489	000
M719GC3THL12SD0	K191489	000
M719GC3THS050	K191489	000
M719GC3THS060	K191489	000
M719GC3THS070	K191489	000
M719GC3THS080	K191489	000
M719GC3THS090	K191489	000
M719GC3THS100	K191489	000
M719GC3THS110	K191489	000
M719GC3THS120	K191489	000
M719GC3THSL10SD0	K191489	000
M719GC3THSL110	K191489	000
M719GC3TS050	K191489	000
M719GC3TS060	K191489	000
M719GC3TS070	K191489	000
M719GC3TS080	K191489	000
M719GC3TS090	K191489	000
M719GC3TS100	K191489	000
M719GC3TS110	K191489	000
M719GC3TS120	K191489	000
M719GAC3D06LC0	K191489	000
M719GC3THSS120	K191489	000
M719GC3THSS110	K191489	000
M719GC3THSL11SD0	K191489	000
M719GC3THSL120	K191489	000
M719GC3THSL12SD0	K191489	000
M719GC3THSS050	K191489	000
M719GC3THSS060	K191489	000
M719GC3THSS070	K191489	000
M719GC3THSS080	K191489	000
M719GC3THSS090	K191489	000
M719GC3THSS100	K191489	000
M719GAC3D07LC0	K191489	000
M719GC3THL11SD0	K191489	000
M719ACC80405L0	K191489	000
M719ACC80411L0	K191489	000
M719GC3100N0	K191489	000
M719GC3100S0	K191489	000
M719GC3RHL050	K191489	000
M719GC3RHL060	K191489	000
M719GC3RHL070	K191489	000
M719GC3RHL080	K191489	000
M719GC3RHL090	K191489	000
M719GC3RHL100	K191489	000
M719ACC80410S0	K191489	000
M719ACC80410L0	K191489	000
M719ACC80405S0	K191489	000
M719ACC80406L0	K191489	000
M719ACC80406S0	K191489	000
M719ACC80407L0	K191489	000
M719ACC80407S0	K191489	000
M719ACC80408L0	K191489	000
M719ACC80408S0	K191489	000
M719ACC80409L0	K191489	000
M719ACC80409S0	K191489	000
M719GC3RHL110	K191489	000
M719GC3RHL120	K191489	000
M719GC3THL06SD0	K191489	000
M719GC3THL070	K191489	000
M719GC3THL07SD0	K191489	000
M719GC3THL080	K191489	000
M719GC3THL08SD0	K191489	000
M719GC3THL090	K191489	000
M719GC3THL09SD0	K191489	000
M719GC3THL100	K191489	000
M719GC3THL10SD0	K191489	000
M719GC3THL060	K191489	000
M719GC3THL05SD0	K191489	000
M719GC3RHS050	K191489	000
M719GC3RHS060	K191489	000
M719GC3RHS070	K191489	000
M719GC3RHS080	K191489	000
M719GC3RHS090	K191489	000
M719GC3RHS100	K191489	000
M719GC3RHS110	K191489	000
M719GC3RHS120	K191489	000
M719GC3THL050	K191489	000
M719GC3THL110	K191489	000
M719GAC3D08LC0	K191489	000
M719GCC3D08L0	K191489	000
M719GCL3D05L0	K191489	000
M719GCL3D05S0	K191489	000
M719GCL3D06L0	K191489	000
M719GCL3D06S0	K191489	000
M719GCL3D07L0	K191489	000
M719GCL3D07S0	K191489	000
M719GCL3D08L0	K191489	000
M719GCL3D08S0	K191489	000
M719GCL3D09L0	K191489	000
M719GCC3D11S0	K191489	000
M719GCC3D10S0	K191489	000
M719GCC3D09L0	K191489	000
M719GCC3D10L0	K191489	000
M719GCC3D11L0	K191489	000
M719GCC3D12L0	K191489	000
M719GCC3D12S0	K191489	000
M719GCC3D06S0	K191489	000
M719GCC3D07S0	K191489	000
M719GCC3D08S0	K191489	000
M719GCC3D09S0	K191489	000
M719GCL3D09S0	K191489	000
M719GCL3D10L0	K191489	000
M719GCP3D08L0	K191489	000
M719GCP3D08S0	K191489	000
M719GCP3D09L0	K191489	000
M719GCP3D09S0	K191489	000
M719GCP3D10L0	K191489	000
M719GCP3D10S0	K191489	000
M719GCP3D11L0	K191489	000
M719GCP3D11S0	K191489	000
M719GCP3D12L0	K191489	000
M719GCP3D07S0	K191489	000
M719GCP3D07L0	K191489	000
M719GCL3D10S0	K191489	000
M719GCL3D11L0	K191489	000
M719GCL3D11S0	K191489	000
M719GCL3D12L0	K191489	000
M719GCL3D12S0	K191489	000
M719GCP3D05L0	K191489	000
M719GCP3D05S0	K191489	000
M719GCP3D06L0	K191489	000
M719GCP3D06S0	K191489	000
M719GCP3D12S0	K191489	000
M719GCC3D07L0	K191489	000
M719GAC3D09LC0	K191489	000
M719GAC3D06SL0	K191489	000
M719GAC3D06SP0	K191489	000
M719GAC3D07LL0	K191489	000
M719GAC3D07LP0	K191489	000
M719GAC3D07SC0	K191489	000
M719GAC3D07SL0	K191489	000
M719GAC3D07SP0	K191489	000
M719GAC3D08LL0	K191489	000
M719GAC3D08LP0	K191489	000
M719GAC3D06SC0	K191489	000
M719GAC3D06LP0	K191489	000
M719GAC3D10LC0	K191489	000
M719GAC3D11LC0	K191489	000
M719GAC3D12LC0	K191489	000
M719GAC3D12SC0	K191489	000
M719GAC3D05LL0	K191489	000
M719GAC3D05LP0	K191489	000
M719GAC3D05SL0	K191489	000
M719GAC3D05SP0	K191489	000
M719GAC3D06LL0	K191489	000
M719GAC3D08SC0	K191489	000
M719GAC3D08SL0	K191489	000
M719GAC3D11LL0	K191489	000
M719GAC3D11LP0	K191489	000
M719GAC3D11SC0	K191489	000
M719GAC3D11SL0	K191489	000
M719GAC3D11SP0	K191489	000
M719GAC3D12LL0	K191489	000
M719GAC3D12LP0	K191489	000
M719GAC3D12SL0	K191489	000
M719GAC3D12SP0	K191489	000
M719GAC3D10SP0	K191489	000
M719GAC3D10SL0	K191489	000
M719GAC3D08SP0	K191489	000
M719GAC3D09LL0	K191489	000
M719GAC3D09LP0	K191489	000
M719GAC3D09SC0	K191489	000
M719GAC3D09SL0	K191489	000
M719GAC3D09SP0	K191489	000
M719GAC3D10LL0	K191489	000
M719GAC3D10LP0	K191489	000
M719GAC3D10SC0	K191489	000
M719GCC3D06L0	K191489	000