The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolution Mp Total Knee System.
Device ID | K093552 |
510k Number | K093552 |
Device Name: | EVOLUTION MP TOTAL KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Ryan Ross |
Correspondent | Ryan Ross WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-17 |
Decision Date | 2010-03-04 |
Summary: | summary |