The following data is part of a premarket notification filed by Fx Solutions with the FDA for Prct2.
| Device ID | K143721 |
| 510k Number | K143721 |
| Device Name: | PRCT2 |
| Classification | Plate, Fixation, Bone |
| Applicant | FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Contact | Jean Jacques Martin |
| Correspondent | Frank Ferguson Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, VA 23451 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037303429 | K143721 | 000 |
| 03701037303092 | K143721 | 000 |
| 03701037303108 | K143721 | 000 |
| 03701037303115 | K143721 | 000 |
| 03701037303139 | K143721 | 000 |
| 03701037303160 | K143721 | 000 |
| 03701037303177 | K143721 | 000 |
| 03701037303184 | K143721 | 000 |
| 03701037303191 | K143721 | 000 |
| 03701037310939 | K143721 | 000 |
| 03701037310922 | K143721 | 000 |
| 03701037310823 | K143721 | 000 |
| 03701037310830 | K143721 | 000 |
| 03701037310847 | K143721 | 000 |
| 03701037310861 | K143721 | 000 |
| 03701037310885 | K143721 | 000 |
| 03701037310892 | K143721 | 000 |
| 03701037310908 | K143721 | 000 |
| 03701037310915 | K143721 | 000 |
| 03701037303207 | K143721 | 000 |
| 03701037301753 | K143721 | 000 |
| 03701037301883 | K143721 | 000 |
| 03701037301890 | K143721 | 000 |
| 03701037301906 | K143721 | 000 |
| 03701037303146 | K143721 | 000 |
| 03701037303382 | K143721 | 000 |
| 03701037303399 | K143721 | 000 |
| 03701037303405 | K143721 | 000 |
| 03701037303412 | K143721 | 000 |
| 03701037301876 | K143721 | 000 |
| 03701037301869 | K143721 | 000 |
| 03701037301760 | K143721 | 000 |
| 03701037301777 | K143721 | 000 |
| 03701037301784 | K143721 | 000 |
| 03701037301791 | K143721 | 000 |
| 03701037301807 | K143721 | 000 |
| 03701037301838 | K143721 | 000 |
| 03701037301845 | K143721 | 000 |
| 03701037301852 | K143721 | 000 |
| 03701037301036 | K143721 | 000 |