The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Incore Mpj System.
| Device ID | K200124 |
| 510k Number | K200124 |
| Device Name: | InCore MPJ System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Contact | Elise Fox |
| Correspondent | Elise Fox Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817701026754 | K200124 | 000 |
| 00817701025900 | K200124 | 000 |
| 00817701025894 | K200124 | 000 |
| 00817701025887 | K200124 | 000 |
| 00817701025870 | K200124 | 000 |
| 00817701025863 | K200124 | 000 |
| 00817701025856 | K200124 | 000 |
| 00817701025849 | K200124 | 000 |
| 00817701025832 | K200124 | 000 |
| 00817701025825 | K200124 | 000 |
| 00817701025917 | K200124 | 000 |
| 00817701025924 | K200124 | 000 |
| 00817701026747 | K200124 | 000 |
| 00817701026006 | K200124 | 000 |
| 00817701025993 | K200124 | 000 |
| 00817701025986 | K200124 | 000 |
| 00817701025979 | K200124 | 000 |
| 00817701025962 | K200124 | 000 |
| 00817701025955 | K200124 | 000 |
| 00817701025948 | K200124 | 000 |
| 00817701025931 | K200124 | 000 |
| 00817701025818 | K200124 | 000 |