The following data is part of a premarket notification filed by The Progressive Orthopaedic Company, Llc with the FDA for Progressive Orthopedic Total Knee System.
Device ID | K142649 |
510k Number | K142649 |
Device Name: | Progressive Orthopedic Total Knee System |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | The Progressive Orthopaedic Company, LLC 801 US Highway 1, Suite B North Palm Beach, FL 33408 |
Contact | Scott Keiser |
Correspondent | Thomas Smith The Progressive Orthopaedic Company, LLC 801 US Highway 1, Suite B North Palm Beach, FL 33408 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-17 |
Decision Date | 2015-03-24 |
Summary: | summary |