Absorbable Cranial Flap Fixation System— 510(k) K221606
Substantially EquivalentChendu Medart Medical Scientific Co., Ltd.
FDA 510(k) clearance K221606 for Absorbable Cranial Flap Fixation System, Substantially Equivalent on 2023-11-21. Applicant: Chendu Medart Medical Scientific Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Chendu Medart Medical Scientific Co., Ltd.
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chengdu, CN
Recent devices under product code GXR
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- K181539 — OSSDSIGN Cranioplug
Data sourced from openFDA. This site is unofficial and independent of the FDA.