The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis A200 Ps Knee System As Part Of The Renovis A200 Knee System.
| Device ID | K190122 |
| 510k Number | K190122 |
| Device Name: | Renovis A200 PS Knee System As Part Of The Renovis A200 Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-25 |
| Decision Date | 2019-06-20 |