The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Cavux Cervicalcage-l Sa System.
| Device ID | K163474 |
| 510k Number | K163474 |
| Device Name: | CAVUX CervicalCage-L SA System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | PROVIDENCE MEDICAL TECHNOLOGY, INC. 1331 N. CALIFORNIA BLVD SUITE 320 Walnut Creek, CA 94596 |
| Contact | Edward Liou |
| Correspondent | Kenneth C. Maxwell Ii EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-03-10 |
| Summary: | summary |