The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Reversed Shoulder.
| Device ID | K162455 |
| 510k Number | K162455 |
| Device Name: | Humelock Reversed Shoulder |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Contact | Jean-jacques Martin |
| Correspondent | Cheryl Hastings FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2017-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037321133 | K162455 | 000 |
| 03701037301432 | K162455 | 000 |
| 03701037301449 | K162455 | 000 |
| 03701037301456 | K162455 | 000 |
| 03701037301913 | K162455 | 000 |
| 03701037302309 | K162455 | 000 |
| 03701037303696 | K162455 | 000 |
| 03701037303702 | K162455 | 000 |
| 03701037303719 | K162455 | 000 |
| 03701037301425 | K162455 | 000 |
| 03701037301418 | K162455 | 000 |
| 03701037321140 | K162455 | 000 |
| 03701037303740 | K162455 | 000 |
| 03701037300084 | K162455 | 000 |
| 03701037300152 | K162455 | 000 |
| 03701037300527 | K162455 | 000 |
| 03701037301388 | K162455 | 000 |
| 03701037301395 | K162455 | 000 |
| 03701037301401 | K162455 | 000 |
| 03701037303733 | K162455 | 000 |
| 03701037303757 | K162455 | 000 |
| 03701037303764 | K162455 | 000 |
| 03701037304686 | K162455 | 000 |
| 03701037304693 | K162455 | 000 |
| 03701037304709 | K162455 | 000 |
| 03701037306376 | K162455 | 000 |
| 03701037307854 | K162455 | 000 |
| 03701037307861 | K162455 | 000 |
| 03701037307946 | K162455 | 000 |
| 03701037307991 | K162455 | 000 |
| 03701037304679 | K162455 | 000 |
| 03701037304662 | K162455 | 000 |
| 03701037303771 | K162455 | 000 |
| 03701037303788 | K162455 | 000 |
| 03701037303795 | K162455 | 000 |
| 03701037303863 | K162455 | 000 |
| 03701037304624 | K162455 | 000 |
| 03701037304631 | K162455 | 000 |
| 03701037304648 | K162455 | 000 |
| 03701037304655 | K162455 | 000 |
| 03701037308004 | K162455 | 000 |