The following data is part of a premarket notification filed by Matortho with the FDA for Saiph Knee System.
Device ID | K140222 |
510k Number | K140222 |
Device Name: | SAIPH KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | MATORTHO 815 KING STREET Alexandria, VA 22314 |
Contact | Marcos Velez-duran |
Correspondent | Marcos Velez-duran MATORTHO 815 KING STREET Alexandria, VA 22314 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-29 |
Decision Date | 2014-11-17 |
Summary: | summary |