K221606 is an FDA 510(k) clearance for the Absorbable Cranial Flap Fixation System. This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by Chendu Medart Medical Scientific Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on November 21, 2023, 537 days after receiving the submission on June 2, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K221606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2022 |
| Decision Date | November 21, 2023 |
| Days to Decision | 537 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXR - Cover, Burr Hole |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5250 |