| Primary Device ID | 07630542730153 |
| NIH Device Record Key | bdbda13c-d665-4e52-b293-cff5164befa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyShoulder Planner |
| Version Model Number | 5.3SSWPL |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07630542730153 [Primary] |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-14 |
| Device Publish Date | 2025-02-06 |
| 07630542720208 - Knee Instruments | 2025-04-17 L/R high collar bushing for stem reference |
| 07630345748041 - Hip Instruments | 2025-04-16 Higher thigh cushion CFB 3.0 |
| 07630345748058 - Hip Instruments | 2025-04-16 Shorter perineal rod CFB 3.0 |
| 07630345748065 - Hip Instruments | 2025-04-16 Shorter perineal rod cushion CFB 3.0 |
| 07630345748072 - Hip Instruments | 2025-04-16 Lateral wing R CFB 3.0 |
| 07630345748089 - Hip Instruments | 2025-04-16 Lateral wing L CFB 3.0 |
| 07630542754333 - Hip Instruments | 2025-04-16 Gaston connection rod |
| 07630542754340 - Hip Instruments | 2025-04-16 Hinge CFB 3.0 Long |