The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Modular Tibial Tray.
| Device ID | K922841 |
| 510k Number | K922841 |
| Device Name: | BIOPRO MODULAR TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1993-09-21 |