The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Rts Lesser Mtp Implant System.
| Device ID | K173491 |
| 510k Number | K173491 |
| Device Name: | RTS Lesser MTP Implant System |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 |
| Contact | Rebecca Wahl |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817906024302 | K173491 | 000 |
| 00817906024296 | K173491 | 000 |
| 00817906024289 | K173491 | 000 |