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 |