Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K252950
Paradigm System · Proprio, Inc. · decided 2025-12-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Paradigm | 1200017 | Proprio, Inc. | OLO | 00850042604205 |
| Paradigm | 1200014 | Proprio, Inc. | OLO | 00850042604175 |
| Paradigm Navigated Drill Guide Case Tray | 1200022 | Proprio, Inc. | OLO | 00850042604236 |
| Paradigm | 1200004 | Proprio, Inc. | OLO | 00850042604069 |
| Paradigm Navigated Drill Guide Case Assembly | 1200021 | Proprio, Inc. | OLO | 00850042604342 |
| Paradigm Drill Bit, 3.0 mm | 1200026 | Proprio, Inc. | OLO | 00850042604298 |
| Paradigm | 1200006 | Proprio, Inc. | OLO | 00850042604083 |
| Paradigm | 1200012 | Proprio, Inc. | OLO | 00850042604120 |
| Paradigm | 1200016 | Proprio, Inc. | OLO | 00850042604199 |
| Paradigm | 1200008 | Proprio, Inc. | OLO | 00850042604151 |
| Paradigm | 1200005 | Proprio, Inc. | OLO | 00850042604076 |
| Paradigm | 1100006 | Proprio, Inc. | OLO | 00850042604014 |
| Paradigm Depth Cannula, 5mm | 1200030 | Proprio, Inc. | OLO | 00850042604328 |
| Paradigm | 1300001 | Proprio, Inc. | OLO | 00850042604267 |
| Paradigm Navigated Drill Guide Case Lid | 1200023 | Proprio, Inc. | OLO | 00850042604243 |
| Paradigm Drill Bit, 2.1 mm | 1200025 | Proprio, Inc. | OLO | 00850042604281 |
| Paradigm Navigated Drill Guide Set | 1200020 | Proprio, Inc. | OLO | 00850042604335 |
| Paradigm | 1200003 | Proprio, Inc. | OLO | 00850042604052 |
| Paradigm Foot Switch | 1100008 | Proprio, Inc. | OLO | 00850042604366 |
| Paradigm | 1200018 | Proprio, Inc. | OLO | 00850042604212 |
| Paradigm | 1200013 | Proprio, Inc. | OLO | 00850042604168 |
| Paradigm | 1200011 | Proprio, Inc. | OLO | 00850042604113 |
| Paradigm | 1200015 | Proprio, Inc. | OLO | 00850042604182 |
| Paradigm Depth Cannula, 2mm | 1200027 | Proprio, Inc. | OLO | 00850042604304 |
| Paradigm Navigated Drill Guide | 1200024 | Proprio, Inc. | OLO | 00850042604274 |