The following data is part of a premarket notification filed by Fx Solutions with the FDA for Humelock Cemented Shoulder Prosthesis.
| Device ID | K111097 |
| 510k Number | K111097 |
| Device Name: | HUMELOCK CEMENTED SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | FX SOLUTIONS 1663 RUE DE MAJORNAS Viriat, FR 01440 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings 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 | 2011-04-20 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701037306994 | K111097 | 000 |
| 03701037303573 | K111097 | 000 |
| 03701037303566 | K111097 | 000 |
| 03701037300497 | K111097 | 000 |
| 03701037300480 | K111097 | 000 |
| 03701037300466 | K111097 | 000 |
| 03701037300435 | K111097 | 000 |
| 03701037300411 | K111097 | 000 |
| 03701037300404 | K111097 | 000 |
| 03701037300381 | K111097 | 000 |
| 03701037303580 | K111097 | 000 |
| 03701037303597 | K111097 | 000 |
| 03701037306987 | K111097 | 000 |
| 03701037306970 | K111097 | 000 |
| 03701037306963 | K111097 | 000 |
| 03701037306956 | K111097 | 000 |
| 03701037306949 | K111097 | 000 |
| 03701037306932 | K111097 | 000 |
| 03701037303634 | K111097 | 000 |
| 03701037303627 | K111097 | 000 |
| 03701037303603 | K111097 | 000 |
| 03701037300510 | K111097 | 000 |