Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K243643
restor3d Reverse Total Shoulder Arthroplasty System · Restor3D · decided 2025-05-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| restor3d Veritas rTSA Instrumentation | 5500-2001 | Restor3d, Inc. | KWS PHX | 00840097512525 |
| restor3d Veritas rTSA Instrumentation | 4520-1002 | Restor3d, Inc. | KWS PHX | 00840097516073 |
| restor3d Veritas rTSA Instrumentation | 5500-9012 | Restor3d, Inc. | KWS PHX | 00840097513355 |
| restor3d Veritas rTSA Instrumentation | 5500-2501 | Restor3d, Inc. | KWS PHX | 00840097512587 |
| Veritas rTSA | 3500-532C3 | Restor3d, Inc. | PHX | 00840097513713 |
| restor3d Veritas rTSA Instrumentation | 5500-2301 | Restor3d, Inc. | KWS PHX | 00840097512556 |
| Veritas rTSA | 1501-3202-N | Restor3d, Inc. | PHX | 00840097534299 |
| Veritas rTSA | 1501-4001 | Restor3d, Inc. | PHX | 00840097515625 |
| restor3d Veritas rTSA Instrumentation | 4520-1003 | Restor3d, Inc. | KWS PHX | 00840097516080 |
| restor3d Veritas rTSA Instrumentation | 5500-3607 | Restor3d, Inc. | KWS PHX | 00840097512846 |
| Veritas rTSA Instrumentation | 5500-1501 | Restor3d, Inc. | PHX | 00840097536637 |
| restor3d Veritas rTSA Instrumentation | 5500-2701 | Restor3d, Inc. | KWS PHX | 00840097512594 |
| Veritas rTSA Instrumentation | 5500-4501 | Restor3d, Inc. | PHX | 00840097535968 |
| Veritas rTSA | 1504-4846 | Restor3d, Inc. | PHX | 00840097515960 |
| Veritas rTSA | 1506-1005 | Restor3d, Inc. | PHX | 00840097515526 |
| restor3d Veritas rTSA Instrumentation | 5500-1911 | Restor3d, Inc. | KWS PHX | 00840097512518 |
| Veritas rTSA | 1501-4204-N | Restor3d, Inc. | PHX | 00840097536491 |
| Veritas rTSA | 1501-3204 | Restor3d, Inc. | PHX | 00840097515571 |
| Veritas rTSA | 1501-3208-N | Restor3d, Inc. | PHX | 00840097536415 |
| Veritas rTSA | 1504-4850 | Restor3d, Inc. | PHX | 00840097515977 |
| Veritas rTSA | 3500-140U1 | Restor3d, Inc. | PHX | 00840097513409 |
| Veritas rTSA | 3500-532U1 | Restor3d, Inc. | PHX | 00840097513621 |
| Veritas rTSA | 1505-4826 | Restor3d, Inc. | PHX | 00840097515793 |
| restor3d Veritas rTSA Instrumentation | 5500-3602 | Restor3d, Inc. | KWS PHX | 00840097512792 |
| restor3d Veritas rTSA Instrumentation | 5500-2901 | Restor3d, Inc. | KWS PHX | 00840097512624 |