K190136 is an FDA 510(k) clearance for the Fusion Silastic System. This device is classified as a Prosthesis, Toe, Constrained, Polymer (Class II - Special Controls, product code KWH).
Submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on October 21, 2019, 265 days after receiving the submission on January 29, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K190136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2019 |
| Decision Date | October 21, 2019 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWH - Prosthesis, Toe, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3720 |