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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06903195108459 K214109 000
06903195109104 K214109 000
06903195109111 K214109 000
06903195109128 K214109 000
06903195109135 K214109 000
06903195109142 K214109 000
06903195109159 K214109 000
06903195109166 K214109 000
06903195109173 K214109 000
06903195109180 K214109 000
06903195109197 K214109 000
06903195109203 K214109 000
06903195109210 K214109 000
06903195109227 K214109 000
06903195109234 K214109 000
06903195109241 K214109 000
06903195109098 K214109 000
06903195109081 K214109 000
06903195108930 K214109 000
06903195108947 K214109 000
06903195108954 K214109 000
06903195108961 K214109 000
06903195108978 K214109 000
06903195108985 K214109 000
06903195108992 K214109 000
06903195109005 K214109 000
06903195109012 K214109 000
06903195109029 K214109 000
06903195109036 K214109 000
06903195109043 K214109 000
06903195109050 K214109 000
06903195109067 K214109 000
06903195109074 K214109 000
06903195109258 K214109 000
06903195109265 K214109 000
06903195109272 K214109 000
06903195107834 K214109 000
06903195107841 K214109 000
06903195107858 K214109 000
06903195107865 K214109 000
06903195107872 K214109 000
06903195107889 K214109 000
06903195107896 K214109 000
06903195107902 K214109 000
06903195107919 K214109 000
06903195107926 K214109 000
06903195107933 K214109 000
06903195107940 K214109 000
06903195107957 K214109 000
06903195107964 K214109 000
06903195107971 K214109 000
06903195107827 K214109 000
06903195107810 K214109 000
06903195109289 K214109 000
06903195109296 K214109 000
06903195109302 K214109 000
06903195109319 K214109 000
06903195109326 K214109 000
06903195109333 K214109 000
06903195109340 K214109 000
06903195107735 K214109 000
06903195107742 K214109 000
06903195107759 K214109 000
06903195107766 K214109 000
06903195107773 K214109 000
06903195107780 K214109 000
06903195107797 K214109 000
06903195107803 K214109 000
06903195107988 K214109 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.