The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Ii Cementless Shoulder System.
| Device ID | K130759 |
| 510k Number | K130759 |
| Device Name: | HUMELOCK II CEMENTLESS SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-20 |
| Decision Date | 2013-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037303672 | K130759 | 000 |
| 03701037301937 | K130759 | 000 |
| 03701037301920 | K130759 | 000 |
| 03701037301098 | K130759 | 000 |
| 03701037301081 | K130759 | 000 |
| 03701037301074 | K130759 | 000 |
| 03701037301067 | K130759 | 000 |
| 03701037302019 | K130759 | 000 |
| 03701037302002 | K130759 | 000 |
| 03701037301029 | K130759 | 000 |
| 03701037301944 | K130759 | 000 |
| 03701037301951 | K130759 | 000 |
| 03701037303665 | K130759 | 000 |
| 03701037303658 | K130759 | 000 |
| 03701037302941 | K130759 | 000 |
| 03701037302934 | K130759 | 000 |
| 03701037302804 | K130759 | 000 |
| 03701037301999 | K130759 | 000 |
| 03701037301982 | K130759 | 000 |
| 03701037301975 | K130759 | 000 |
| 03701037301968 | K130759 | 000 |
| 03701037301043 | K130759 | 000 |