| Primary Device ID | 03701037315453 |
| NIH Device Record Key | 69df12f4-7a35-4e6f-a93d-0a44b0b47801 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX V 135 humeral spacer |
| Version Model Number | 203-0007 |
| Catalog Number | 203-0007 |
| 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 | false |
| 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 | 03701037315453 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-21 |
| Device Publish Date | 2022-06-10 |
| 03701037311776 - Humelock II | 2025-08-11 BONE GRAFT CUTTER |
| 03701037311783 - Humelock II | 2025-08-11 BONE GRAFT CUTTER |
| 03701037311790 - Humelock II | 2025-08-11 BONE GRAFT CUTTER |
| 03701037311806 - Humelock II | 2025-08-11 BONE GRAFT CUTTER |
| 03701037311813 - Humelock II | 2025-08-11 BONE GRAFT CUTTER |
| 03701037316450 - FX V135 | 2025-08-11 STABILITY TRIAL CUP 135-145° FOR IMPLANT Ø36 +3 |
| 03701037321133 - Humelock Reversed | 2025-08-11 HOLE SAW Ø26mm H14mm WITH DRILL Ø8mm/HUDSON |
| 03701037321140 - Humelock Reversed Shoulder | 2025-08-11 STARTER Ø06mm / HUDSON |