| Primary Device ID | 07630040706353 |
| NIH Device Record Key | b5228d62-5b9b-43b7-b5a4-53f6dcdc3d9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shoulder System |
| Version Model Number | 04.01.0148 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | 07630040706353 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-15 |
| 07630040719964 | Glenoid Polyaxial non-locking screw – L50 |
| 07630040719957 | Glenoid Polyaxial non-locking screw – L46 |
| 07630040719940 | Glenoid Polyaxial non-locking screw – L42 |
| 07630040719933 | Glenoid Polyaxial non-locking screw – L38 |
| 07630040719926 | Glenoid Polyaxial non-locking screw – L34 |
| 07630040719919 | Glenoid Polyaxial non-locking screw – L30 |
| 07630040719902 | Glenoid Polyaxial non-locking screw – L26 |
| 07630040719896 | Glenoid Polyaxial non-locking screw – L22 |
| 07630040719889 | Glenoid Polyaxial non-locking screw – L18 |
| 07630040719872 | Glenoid Polyaxial non-locking screw – L14 |
| 07630040715492 | Threaded glenoid baseplate Ø27x30 |
| 07630040715485 | Threaded glenoid baseplate Ø27x25 |
| 07630040715478 | Threaded glenoid baseplate Ø24.5x30 |
| 07630040708135 | Glenoidsphere 32xØ24.5 |
| 07630040708098 | Threaded glenoid baseplate Ø24.5x25 |
| 07630040706636 | Glenoidsphere screw |
| 07630040706629 | Double Eccenter / Reverse metaphysis screw |
| 07630040706612 | Glenoidsphere 42x27 |
| 07630040706605 | Glenoidsphere 39xØ27 |
| 07630040706599 | Glenoidsphere 36xØ27 |
| 07630040706582 | Glenoidsphere 42xØ24.5 |
| 07630040706575 | Glenoidsphere 39xØ24.5 |
| 07630040706568 | Glenoidsphere 36xØ24.5 |
| 07630040706551 | Glenoidsphere 36xØ22 |
| 07630040706544 | Glenoidsphere 32xØ22 |
| 07630040706537 | Glenoid polyaxial locking screw - L50 |
| 07630040706520 | Glenoid polyaxial locking screw - L46 |
| 07630040706513 | Glenoid polyaxial locking screw - L42 |
| 07630040706506 | Glenoid polyaxial locking screw - L38 |
| 07630040706490 | Glenoid polyaxial locking screw - L34 |
| 07630040706483 | Glenoid polyaxial locking screw - L30 |
| 07630040706476 | Glenoid polyaxial locking screw - L26 |
| 07630040706469 | Glenoid polyaxial locking screw - L22 |
| 07630040706452 | Glenoid polyaxial locking screw - L18 |
| 07630040706445 | Glenoid polyaxial locking screw - L14 |
| 07630040706438 | Glenoid baseplate Ø27x35 |
| 07630040706421 | Glenoid baseplate Ø27x25 |
| 07630040706414 | Glenoid baseplate Ø27x15 |
| 07630040706407 | Glenoid baseplate Ø24.5x35 |
| 07630040706391 | Glenoid baseplate Ø24.5x25 |
| 07630040706384 | Glenoid baseplate Ø24.5x15 |
| 07630040706377 | Glenoid baseplate Ø22x35 |
| 07630040706360 | Glenoid baseplate Ø22x25 |
| 07630040706353 | Glenoid baseplate Ø22x15 |
| 07630040706346 | Humeral Reverse HC Liner Ø42/+6mm |
| 07630040706339 | Humeral Reverse HC Liner Ø42/+3mm |
| 07630040706322 | Humeral Reverse HC Liner Ø42/+0mm |
| 07630040706315 | Humeral Reverse HC Liner Ø39/+6mm |
| 07630040706308 | Humeral Reverse HC Liner Ø39/+3mm |
| 07630040706292 | Humeral Reverse HC Liner Ø39/+0mm |