The following data is part of a premarket notification filed by Engineering Consulting Services, Inc. with the FDA for Medial Rotation Knee System.
Device ID | K020214 |
510k Number | K020214 |
Device Name: | MEDIAL ROTATION KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH ST. Prior Lake, MN 55372 |
Contact | Al Lippincott |
Correspondent | Al Lippincott ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH ST. Prior Lake, MN 55372 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-22 |
Decision Date | 2002-02-26 |
Summary: | summary |