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 |