K210616 is an FDA 510(k) clearance for the Longeviti PMMA Static Cranial Implant. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on March 31, 2021, 30 days after receiving the submission on March 1, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K210616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | March 31, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXN - Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |