The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Restoris Multi-compartmental Knee System.
Device ID | K220930 |
510k Number | K220930 |
Device Name: | Restoris Multi-Compartmental Knee System |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
Applicant | Mako Surgical Corp. 3365 Enterprise Ave Weston, FL 33331 |
Contact | Emily DiMambro |
Correspondent | Emily DiMambro Mako Surgical Corp. 3365 Enterprise Ave Weston, FL 33331 |
Product Code | HSX |
Subsequent Product Code | HRY |
Subsequent Product Code | KRR |
Subsequent Product Code | NPJ |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-31 |
Decision Date | 2022-06-02 |