Binary® Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Genesys Spine

The following data is part of a premarket notification filed by Genesys Spine with the FDA for Binary® Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K192076
• 510k Number: K192076
• Device Name: Binary® Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746
• Contact: Andrew C. Davison C. Davison
• Correspondent: Andrew C. Davison Davison; Genesys Spine 1250 Capital Of Texas Highway South Building 3, Suite 600 Austin, TX 78746
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-02
• Decision Date: 2019-08-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M719GCP2AV40180	K192076	000
M719GCP2AV40160	K192076	000
M719GCP2AV40140	K192076	000
M719GCP2AV40120	K192076	000
M719GCP2AV40100	K192076	000