The following data is part of a premarket notification filed by In2bonesusa, Llc with the FDA for Rts Flexible 1 Mpj Implant W/grommets.
| Device ID | K153609 |
| 510k Number | K153609 |
| Device Name: | RTS Flexible 1 MPJ Implant W/Grommets |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | In2BonesUSA, LLC 6060 Poplar Ave, Suite 380 Mephis, TN 38119 |
| Contact | Joe Clift |
| Correspondent | Louise Focht ENMED International, Inc PO Box 249 Del Mar, CA 92014 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817906020069 | K153609 | 000 |
| 00817906020052 | K153609 | 000 |
| 00817906020045 | K153609 | 000 |
| 00817906020038 | K153609 | 000 |
| 00817906020021 | K153609 | 000 |
| 00817906020014 | K153609 | 000 |
| 00817906020007 | K153609 | 000 |