K223445 is an FDA 510(k) clearance for the ArtiFascia. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Nurami Medical , Ltd. (Haifa, IL). The FDA issued a Cleared decision on August 10, 2023, 269 days after receiving the submission on November 14, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K223445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2022 |
| Decision Date | August 10, 2023 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ - Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |