K233172 is an FDA 510(k) clearance for the NextAR™ Spine 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 April 24, 2024, 209 days after receiving the submission on September 28, 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 | K233172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | April 24, 2024 |
| Days to Decision | 209 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. |