The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Hemi-edge Toe System.
| Device ID | K121973 |
| 510k Number | K121973 |
| Device Name: | BIOPRO HEMI-EDGE TOE SYSTEM |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | BIOPRO, INC. 3150 E. 200TH ST Prior Lake, MN 55372 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott BIOPRO, INC. 3150 E. 200TH ST Prior Lake, MN 55372 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2012-10-30 |
| Summary: | summary |