FDA Product Code
FDA Product Code SBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261854 | xvision Spine system | Augmedics, Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K253805 | Knee+ | Pixee Medical S.A.S. | 2026-04-24 | Traditional | PDF ↗ |
| K252847 | NextAR Hip Platform | Medacta International S.A. | 2026-01-09 | Traditional | PDF ↗ |
| K251639 | xvision Spine system | Augmedics, Ltd. | 2025-10-03 | Traditional | PDF ↗ |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025-09-29 | Traditional | PDF ↗ |
| K252530 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-09-10 | Special | PDF ↗ |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | 2025-09-04 | Traditional | PDF ↗ |
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-08-08 | Special | PDF ↗ |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | 2025-07-31 | Traditional | PDF ↗ |
| K250108 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-07-09 | Traditional | PDF ↗ |
| K241525 | ExcelsiusXR | Globus Medical, Inc. | 2025-07-08 | Traditional | PDF ↗ |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025-05-16 | Traditional | PDF ↗ |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025-03-21 | Special | PDF ↗ |
| K243975 | Knee+ | Pixee Medical | 2025-03-20 | Traditional | PDF ↗ |
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025-03-13 | Special | PDF ↗ |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 | Special | PDF ↗ |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024-12-24 | Special | PDF ↗ |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K241481 | xvision Spine System | Augmedics, Ltd. | 2024-10-16 | Traditional | PDF ↗ |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2024-08-19 | Special | PDF ↗ |
| K233172 | NextAR Spine Platform | Medacta International S.A. | 2024-04-24 | Traditional | PDF ↗ |
| K233899 | Knee+ | Pixee Medical | 2024-03-08 | Traditional | PDF ↗ |
| K232176 | STELLAR Knee | Polarisar, Inc. | 2023-11-02 | Traditional | PDF ↗ |
| K232280 | NextAR TSA Platform | Medacta International S.A. | 2023-10-29 | Traditional | PDF ↗ |
| K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2023-09-08 | Traditional | PDF ↗ |
| K231611 | HOLO Portal Surgical Guidance System | Surgalign Spine Technologies | 2023-08-31 | Traditional | PDF ↗ |
| K223769 | NextAR Spine Platform | Medacta International S.A. | 2023-07-21 | Traditional | PDF ↗ |
| K230567 | OptiVu ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 | Traditional | PDF ↗ |
| K230789 | Knee+ | Pixee Medical | 2023-04-21 | Special | PDF ↗ |
| K220554 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K220905 | xvision Spine System | Augmedics, Ltd. | 2022-11-17 | Traditional | PDF ↗ |
| K213034 | SpineAR SNAP | Surgical Theater, Inc. | 2022-09-29 | Traditional | PDF ↗ |
| K220104 | Knee+ | Pixee Medical | 2022-09-01 | Traditional | PDF ↗ |
| K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 | Traditional | PDF ↗ |
| K213751 | NextAR TKA Platform My Knee PPS | Medacta International S.A. | 2022-03-10 | Traditional | PDF ↗ |
| K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | 2022-01-14 | Traditional | PDF ↗ |
| K210859 | NextAR Spine Platform | Medacta International S.A. | 2021-11-05 | Traditional | PDF ↗ |
| K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | 2021-07-19 | Traditional | PDF ↗ |
| K210153 | NextAR RSA Platform | Medacta International S.A. | 2021-05-12 | Traditional | PDF ↗ |
| K202750 | Knee+ | Pixee Medical | 2021-04-21 | Traditional | PDF ↗ |
| K202152 | NextAR TKA Platform | Medacta International S.A. | 2020-10-27 | Traditional | PDF ↗ |
| K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020-07-10 | Traditional | PDF ↗ |
| K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019-12-20 | Traditional | PDF ↗ |
Product code SBF · Class II · Neurology. Data: openFDA.