PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Plate, Cranioplasty, Preformed, Non-alterable

Kontour(Xi’an) Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Kontour(xi’an) Medical Technology Co., Ltd. with the FDA for Peek Patient Specific Cranial/craniofacial Implant(psci).

Pre-market Notification Details

Device IDK214109
510k NumberK214109
Device Name:PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant Kontour(Xi’an) Medical Technology Co., Ltd. No.6, Qinling Avenue, Caotang Technology Industries Base Xi’an High-tech Zone, Xi'an,  CN 710304
ContactRongrong Cong
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen,  CN 518100
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-29
Decision Date2022-10-28

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