The following data is part of a premarket notification filed by The Progressive Orthopaedic Company, Llc with the FDA for Progressive Orthopaedic Total Knee System.
| Device ID | K150783 |
| 510k Number | K150783 |
| Device Name: | Progressive Orthopaedic 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 | 2015-03-25 |
| Decision Date | 2015-06-23 |
| Summary: | summary |