510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221606Substantially Equivalent

Absorbable Cranial Flap Fixation System

Chendu Medart Medical Scientific Co., Ltd., Chengdu, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221606 is the FDA 510(k) clearance record for Absorbable Cranial Flap Fixation System, a class II device, cleared for Chendu Medart Medical Scientific Co., Ltd. on under FDA product code GXR (Cover, Burr Hole). FDA records list one 510(k) clearance for Chendu Medart Medical Scientific Co., Ltd. As of , FDA records show no recalls naming K221606.

Clearance record

Decision date
Received
(537 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Chendu Medart Medical Scientific Co., Ltd. # 102, Tianying Rd.,, Chengdu, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXR

Trailing 12 months
1 clearance under product code GXR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260