510(k) K232280
- Device
- NextAR TSA Platform
- Applicant
- Medacta International S.A.
- 510(k) number
- K232280
- Product code
- SBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-29
- Date received
- 2023-07-31
- Regulation
- 882.4560
- Classification name
- Orthopedic Augmented Reality
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro (Ch) CH CH-6874 CH-6874
FDA Registration Numbers
- 3005180920
- 9617840
- 3016566146
- 3016676864
- 3033509898
- 3043520095
- 3010047454
- 3036756245
- 3025287527
- 3016438694
- 3008110533
- 3009973505
- 2032098
- 8043933
- 9681465
- 3010197287
- 3010031846
- 3008869747
- 3020703212
- 3007441485
- 3025603301
- 3015151147
- 3006946276
- 8010468
- 3010163695
- 3004142400
- 3006017180
- 3014232530
- 8043792
- 3013552417
- 1526534
- 3016571711
- 3016534677
- 3019878658
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 07630542723155 | NextAR TSA Platform | Medacta International SA | 2024-03-08 |
| 07630542723117 | NextAR TSA Platform | Medacta International SA | 2024-03-08 |
| 07630542723100 | NextAR TSA Platform | Medacta International SA | 2024-03-08 |
| 07630542723094 | NextAR TSA Platform | Medacta International SA | 2024-03-08 |
| 07630542723087 | NextAR TSA Platform | Medacta International SA | 2024-03-08 |
Other 510(k) Records For Product Code SBF
| 510(k) | Device | Applicant | Decision date |
|---|
| K253805 | Knee+ | Pixee Medical S.A.S. | 2026-04-24 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | 2026-01-09 |
| K251639 | xvision Spine system | Augmedics, Ltd. | 2025-10-03 |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025-09-29 |
| K252530 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-09-10 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | 2025-09-04 |
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-08-08 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | 2025-07-31 |
| K250108 | OptiVu Shoulder | Mr Surgical Solutions, LLC | 2025-07-09 |
| K241525 | ExcelsiusXR | Globus Medical, Inc. | 2025-07-08 |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025-05-16 |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
| K243975 | Knee+ | Pixee Medical | 2025-03-20 |
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025-03-13 |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |