K173491 is an FDA 510(k) clearance for the RTS Lesser MTP Implant System. This device is classified as a Prosthesis, Toe, Constrained, Polymer (Class II - Special Controls, product code KWH).
Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on February 23, 2018, 102 days after receiving the submission on November 13, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K173491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | February 23, 2018 |
| Days to Decision | 102 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 |