FX V135
GUDID 00840452402539
STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+6
FX Shoulder Solutions, Inc.
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 00840452402539 |
| NIH Device Record Key | 982567fc-ea7c-492a-9348-b9299811d4fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX V135 |
| Version Model Number | 950-3806 |
| Company DUNS | 115052068 |
| Company Name | FX Shoulder Solutions, Inc. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840452402539 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223801
FDA Product Code
| PHX | Shoulder Prosthesis, Reverse Configuration |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
[00840452402539]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-03 |
| Device Publish Date | 2025-08-26 |
On-Brand Devices [FX V135]
| 00840452402492 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+12 |
| 00840452402478 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+6 |
| 00840452402461 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+3 |
| 00840452402454 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+18 |
| 00840452402447 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+15 |
| 00840452402430 | 950-1812 |
| 00840452402423 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+9 |
| 00840452402416 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+6 |
| 00840452402409 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø32+3 |
| 00840452402751 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+18 |
| 00840452402744 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+15 |
| 00840452402737 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+12 |
| 00840452402720 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+9 |
| 00840452402713 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+6 |
| 00840452402706 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø40+3 |
| 00840452402690 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+18 |
| 00840452402683 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+15 |
| 00840452402676 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+12 |
| 00840452402669 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+9 |
| 00840452402652 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+6 |
| 00840452402645 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø36+3 |
| 00840452402638 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+18 |
| 00840452402621 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+15 |
| 00840452402614 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+12 |
| 00840452402607 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+9 |
| 00840452402591 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+6 |
| 00840452402584 | STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+3 |
| 00840452402577 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+18 |
| 00840452402560 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+15 |
| 00840452402553 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+12 |
| 00840452402546 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+9 |
| 00840452402539 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+6 |
| 00840452402522 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø40+3 |
| 00840452402515 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+18 |
| 00840452402508 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+15 |
| 00840452402485 | STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+9 |
Trademark Results [FX V135]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FX V135 97481531 not registered Live/Pending |
FX SOLUTIONS 2022-06-29 |
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