K231611 is an FDA 510(k) clearance for the HOLO Portal™ Surgical Guidance System. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).
Submitted by Surgalign Spine Technologies (Deerfield, US). The FDA issued a Cleared decision on August 31, 2023, 90 days after receiving the submission on June 2, 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 | K231611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2023 |
| Decision Date | August 31, 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. |