The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis Tesera C/tesera Sc Anterior Cervical Fusion (acf) System.
| Device ID | K182007 |
| 510k Number | K182007 |
| Device Name: | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Renovis Surgical Technologies 1901 W. Lugonia Ave., Suite 340 Redlands, CA 92374 |
| Contact | Anthony Debenedictis |
| Correspondent | Sharyn Orton MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | OVD |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-12-07 |
| Summary: | summary |