K121973 is an FDA 510(k) clearance for the BIOPRO HEMI-EDGE TOE SYSTEM. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Biopro, Inc. (Prior Lake, US). The FDA issued a Cleared decision on October 30, 2012, 117 days after receiving the submission on July 5, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K121973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2012 |
| Decision Date | October 30, 2012 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |