510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K214109Substantially Equivalent

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Kontour (Xi'an) Medical Technology Co., Ltd., Xi'An, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214109 is the FDA 510(k) clearance record for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI), a class II device, cleared for Kontour(Xi’An) Medical Technology Co., Ltd. on under FDA product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable). FDA records list one 510(k) clearance for Kontour(Xi’An) Medical Technology Co., Ltd. As of , FDA records show no recalls naming K214109.

Clearance record

Decision date
Received
(303 days to decision)
Product code
GXN Plate, Cranioplasty, Preformed, Non-Alterable
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Applicant
Kontour(Xi’An) Medical Technology Co., Ltd. #6, Qinling Ave., Caotang Technology Industries Base, Xi'An, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXN

Trailing 12 months
6 clearances under product code GXN in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GXN, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260