| Primary Device ID | 03701037300510 |
| NIH Device Record Key | 0d847b9a-1d2f-44b0-828d-d0b7381d998e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Humelock Cemented Shoulder System |
| Version Model Number | 106-5000 |
| Company DUNS | 263076196 |
| Company Name | FX SOLUTIONS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037300510 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2024-01-22 |
| 03701037319512 - Full wedge baseplates | 2025-06-23 GUIDE BROCHE TOTAL AUGMENTE 7,5 |
| 03701037318669 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø32/10 LG 120MM FX V135 |
| 03701037318676 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø32/12 LG 120MM FX V135 |
| 03701037318683 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø36/10 LG 120MM FX V135 |
| 03701037318690 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø36/12 LG 120MM FX V135 |
| 03701037318706 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø36/14 LG 120MM FX V135 |
| 03701037318713 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø40/12 LG 120MM FX V135 |
| 03701037318737 - FX V135 Shoulder Prosthesis | 2025-04-17 BROACH Ø40/16 LG 120MM FX V135 |