The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Oryx Cervical Plate System.
| Device ID | K192049 |
| 501k Number | K192049 |
| Device Name: | Oryx Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Orthopedic |
| 501k Review Panel | Orthopedic |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-11-08 |