The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Townley Total Knee (ttk).
| Device ID | K904448 |
| 510k Number | K904448 |
| Device Name: | TOWNLEY TOTAL KNEE (TTK) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin 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 | 1990-09-28 |
| Decision Date | 1991-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209118010 | K904448 | 000 |
| M209118000 | K904448 | 000 |
| M209117990 | K904448 | 000 |
| M209117980 | K904448 | 000 |
| M209117970 | K904448 | 000 |
| M209117960 | K904448 | 000 |
| M209117790 | K904448 | 000 |
| M209117780 | K904448 | 000 |
| M209103170 | K904448 | 000 |