K220357 is an FDA 510(k) clearance for the MedCAD AccuShape Titanium Patient-Specific Cranial Implant. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on August 26, 2022, 199 days after receiving the submission on February 8, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K220357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2022 |
| Decision Date | August 26, 2022 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN - Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |