K153609 is an FDA 510(k) clearance for the RTS Flexible 1 MPJ Implant w/Grommets. 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 September 8, 2016, 266 days after receiving the submission on December 17, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K153609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2015 |
| Decision Date | September 08, 2016 |
| Days to Decision | 266 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 |