K941650 is an FDA 510(k) clearance for the TOTAL TOE SYSTEM II. This device is classified as a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained.
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 19, 1994, 258 days after receiving the submission on April 5, 1994.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K941650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1994 |
| Decision Date | December 19, 1994 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LZJ — Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Device Class | — |