The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Ii Cemented Shoulder System.
| Device ID | K140071 |
| 510k Number | K140071 |
| Device Name: | HUMELOCK II CEMENTED SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Contact | Jean-jacques Martin |
| Correspondent | Jean-jacques Martin FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-07-28 |
| Summary: | summary |