The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Townley Great Toe Joint.
| Device ID | K911378 |
| 510k Number | K911378 |
| Device Name: | TOWNLEY GREAT TOE JOINT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Contact | Michael G Gorman |
| Correspondent | Michael G Gorman BIOPRO, INC. 17 17TH ST. Port Huron, MI 48060 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-11-22 |