Cleared Traditional

Absorbable Cranial Flap Fixation System

K221606 · Chendu Medart Medical Scientific Co., Ltd. · Neurology

Nov 2023

Decision

537d

Days

Class 2

Risk

About This 510(k) Submission

K221606 is an FDA 510(k) clearance for the Absorbable Cranial Flap Fixation System, 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 review panel. Regulated under 21 CFR 882.5250.

Submission Details

510(k) Number	K221606 FDA.gov
FDA Decision	Cleared 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