| Primary Device ID | 03701037317099 |
| NIH Device Record Key | afe55815-a8c5-4bc8-954b-c76896177425 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX V135 Shoulder Prosthesis |
| Version Model Number | 206-4634 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037317099 [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 | 2024-01-31 |
| Device Publish Date | 2024-01-23 |
| 03701037315408 | 203-0906 FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +6 |
| 03701037315392 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +3 |
| 03701037315385 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +9 |
| 03701037315378 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +6 |
| 03701037315361 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +3 |
| 03701037315323 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9 |
| 03701037315316 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6 |
| 03701037315309 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3 |
| 03701037315293 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +9 |
| 03701037315286 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +6 |
| 03701037315279 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3 |
| 03701037317174 | OFFSET HEAD 50x22 |
| 03701037317167 | OFFSET HEAD 50x18 |
| 03701037317150 | CENTERED HEAD 50x21 |
| 03701037317143 | CENTERED HEAD 50x17 |
| 03701037317136 | OFFSET HEAD 48x21 |
| 03701037317129 | OFFSET HEAD 48x17 |
| 03701037317112 | CENTERED HEAD 48x20 |
| 03701037317105 | CENTERED HEAD 48x16 |
| 03701037317099 | OFFSET HEAD 46x20 |
| 03701037317082 | OFFSET HEAD 46x16 |
| 03701037317075 | CENTERED HEAD 46x19 |
| 03701037317068 | CENTERED HEAD 46x15 |
| 03701037317051 | OFFSET HEAD 43x19 |
| 03701037317044 | OFFSET HEAD 43x15 |
| 03701037317037 | CENTERED HEAD 43x18 |
| 03701037317020 | CENTERED HEAD 43x14 |
| 03701037317013 | OFFSET HEAD 41x18 |
| 03701037317006 | OFFSET HEAD 41x14 |
| 03701037316993 | CENTERED HEAD 41x17 |
| 03701037316986 | CENTERED HEAD 41x13 |
| 03701037316979 | OFFSET HEAD 39x17 |
| 03701037316962 | OFFSET HEAD 39x13 |
| 03701037316955 | CENTERED HEAD 39x16 |
| 03701037316948 | CENTERED HEAD 39x13 |
| 03701037315446 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9 |
| 03701037315439 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6 |
| 03701037315422 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3 |
| 03701037315415 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +9 |
| 03701037315354 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +9 |
| 03701037315347 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6 |
| 03701037315330 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 |
| 03701037320396 | Glenoid Manual Reamer Ø36mm |
| 03701037320389 | Glenoid Manual Reamer Ø40mm |
| 03701037318973 | FX V135 PLATE FOR CUPULAR ROLE SAW |
| 03701037318966 | INLAY CUP HOLE SAW Ø36mm |
| 03701037318652 | BROACH Ø32/08 LG 120MM FX V135 |
| 03701037318737 | BROACH Ø40/16 LG 120MM FX V135 |
| 03701037318713 | BROACH Ø40/12 LG 120MM FX V135 |
| 03701037318706 | BROACH Ø36/14 LG 120MM FX V135 |