The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Ii Cemented Shoulder System.
| Device ID | K123814 |
| 510k Number | K123814 |
| 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 | 2012-12-12 |
| Decision Date | 2013-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037302958 | K123814 | 000 |
| 03701037301104 | K123814 | 000 |
| 03701037301111 | K123814 | 000 |
| 03701037301128 | K123814 | 000 |
| 03701037301135 | K123814 | 000 |
| 03701037301142 | K123814 | 000 |
| 03701037301159 | K123814 | 000 |
| 03701037301166 | K123814 | 000 |
| 03701037301180 | K123814 | 000 |
| 03701037300732 | K123814 | 000 |
| 03701037300503 | K123814 | 000 |
| 03701037300473 | K123814 | 000 |
| 03701037302965 | K123814 | 000 |
| 03701037302972 | K123814 | 000 |
| 03701037302989 | K123814 | 000 |
| 03701037302996 | K123814 | 000 |
| 03701037303009 | K123814 | 000 |
| 03701037300398 | K123814 | 000 |
| 03701037300428 | K123814 | 000 |
| 03701037300442 | K123814 | 000 |
| 03701037301197 | K123814 | 000 |
| 03701037301203 | K123814 | 000 |
| 03701037304754 | K123814 | 000 |
| 03701037304761 | K123814 | 000 |
| 03701037304778 | K123814 | 000 |
| 03701037304792 | K123814 | 000 |
| 03701037304808 | K123814 | 000 |
| 03701037300169 | K123814 | 000 |
| 03701037300176 | K123814 | 000 |
| 03701037300183 | K123814 | 000 |
| 03701037304747 | K123814 | 000 |
| 03701037304730 | K123814 | 000 |
| 03701037304723 | K123814 | 000 |
| 03701037301210 | K123814 | 000 |
| 03701037301227 | K123814 | 000 |
| 03701037301234 | K123814 | 000 |
| 03701037303313 | K123814 | 000 |
| 03701037303320 | K123814 | 000 |
| 03701037303337 | K123814 | 000 |
| 03701037303344 | K123814 | 000 |
| 03701037304716 | K123814 | 000 |
| 03701037300190 | K123814 | 000 |