K221606
- 510(k) number
- K221606
- Device name
- Absorbable Cranial Flap Fixation System
- Applicant
- Chendu Medart Medical Scientific Co., Ltd. CN
- Product code
- GXR — Cover, Burr Hole
- Decision date
- 2023-11-21
- Date received
- 2022-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K221606.pdf
Official FDA record: K221606
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.