The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Anterior Cervical Plate System.
| Device ID | K111132 |
| 510k Number | K111132 |
| Device Name: | GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | Brian J Bergeron |
| Correspondent | Brian J Bergeron GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2011-12-09 |
| Summary: | summary |