K232280 is an FDA 510(k) clearance for the NextAR™ TSA Platform. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).
Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on October 29, 2023, 90 days after receiving the submission on July 31, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As augmented Reality Stereoscopic Images To Intraoperatively Augment The Users Field Of View..
| 510(k) Number | K232280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2023 |
| Decision Date | October 29, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | SBF — Orthopedic Augmented Reality |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As augmented Reality Stereoscopic Images To Intraoperatively Augment The Users Field Of View. |