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 |