K241481 is an FDA 510(k) clearance for the xvision Spine System. This device is classified as a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF).
Submitted by Augmedics, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on October 16, 2024, 145 days after receiving the submission on May 24, 2024.
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 User?s Field Of View..
| 510(k) Number | K241481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 145 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 User?s Field Of View. |