The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Myknee Cutting Blocks.
Device ID | K093806 |
510k Number | K093806 |
Device Name: | MYKNEE CUTTING BLOCKS |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
Contact | Natalie J Kennel |
Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-11 |
Decision Date | 2010-04-08 |
Summary: | summary |