The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Binary® Lumbar Plate System.
| Device ID | K192678 |
| 510k Number | K192678 |
| Device Name: | Genesys Spine Binary® Lumbar Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, TX 78746 |
| Contact | Chloe Lance |
| Correspondent | Chloe Lance 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 | 2019-09-26 |
| Decision Date | 2019-10-24 |
| Summary: | summary |