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 ID: K214109
• 510k Number: K214109
• Device Name: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
• Classification: Plate, 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
• Contact: Rongrong Cong
• Correspondent: Joyce Yang; Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, CN 518100
• Product Code: GXN
• CFR Regulation Number: 882.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-29
• Decision Date: 2022-10-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M384CF260400050	K214109	000
M384CF260500020	K214109	000
M384CF260500030	K214109	000
M384CF260500040	K214109	000
M384CF260500050	K214109	000
M384CF260500060	K214109	000
M384CF260500070	K214109	000
M384CF260500080	K214109	000
M384CF260500090	K214109	000
M384CF260500100	K214109	000
M384CF260500110	K214109	000
M384CF260500120	K214109	000
M384CF260500130	K214109	000
M384CF260500010	K214109	000
M384CF260400180	K214109	000
M384CF260400060	K214109	000
M384CF260400070	K214109	000
M384CF260400080	K214109	000
M384CF260400090	K214109	000
M384CF260400100	K214109	000
M384CF260400110	K214109	000
M384CF260400120	K214109	000
M384CF260400130	K214109	000
M384CF260400140	K214109	000
M384CF260400150	K214109	000
M384CF260400160	K214109	000
M384CF260400170	K214109	000
M384CF260500140	K214109	000
M384CF260500150	K214109	000
M384CF260500160	K214109	000
M384CF260600130	K214109	000
M384CF260600140	K214109	000
M384CF260600150	K214109	000
M384CF260600160	K214109	000
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M384CF260700010	K214109	000
M384CF260700020	K214109	000
M384CF260700030	K214109	000
M384CF260700040	K214109	000
M384CF260700050	K214109	000
M384CF260700060	K214109	000
M384CF260600120	K214109	000
M384CF260600110	K214109	000
M384CF260500170	K214109	000
M384CF260500180	K214109	000
M384CF260600010	K214109	000
M384CF260600020	K214109	000
M384CF260600030	K214109	000
M384CF260600040	K214109	000
M384CF260600050	K214109	000
M384CF260600060	K214109	000
M384CF260600070	K214109	000
M384CF260600080	K214109	000
M384CF260600090	K214109	000
M384CF260600100	K214109	000
M384CF260700070	K214109	000
M384CF260400040	K214109	000
M384CF260100010	K214109	000
M384CF260100160	K214109	000
M384CF260100170	K214109	000
M384CF260100180	K214109	000
M384CF260200010	K214109	000
M384CF260200020	K214109	000
M384CF260200030	K214109	000
M384CF260200040	K214109	000
M384CF260200050	K214109	000
M384CF260200060	K214109	000
M384CF260200070	K214109	000
M384CF260200080	K214109	000
M384CF260200090	K214109	000
M384CF260100150	K214109	000
M384CF260100140	K214109	000
M384CF260100020	K214109	000
M384CF260100030	K214109	000
M384CF260100040	K214109	000
M384CF260100050	K214109	000
M384CF260100060	K214109	000
M384CF260100070	K214109	000
M384CF260100080	K214109	000
M384CF260100090	K214109	000
M384CF260100100	K214109	000
M384CF260100110	K214109	000
M384CF260100120	K214109	000
M384CF260100130	K214109	000
M384CF260200100	K214109	000
M384CF260200110	K214109	000
M384CF260200120	K214109	000
M384CF260300090	K214109	000
M384CF260300100	K214109	000
M384CF260300110	K214109	000
M384CF260300120	K214109	000
M384CF260300130	K214109	000
M384CF260300140	K214109	000
M384CF260300150	K214109	000
M384CF260300160	K214109	000
M384CF260300170	K214109	000
M384CF260300180	K214109	000
M384CF260400010	K214109	000
M384CF260400020	K214109	000
M384CF260300080	K214109	000
M384CF260300070	K214109	000
M384CF260200130	K214109	000
M384CF260200140	K214109	000
M384CF260200150	K214109	000
M384CF260200160	K214109	000
M384CF260200170	K214109	000
M384CF260200180	K214109	000
M384CF260300010	K214109	000
M384CF260300020	K214109	000
M384CF260300030	K214109	000
M384CF260300040	K214109	000
M384CF260300050	K214109	000
M384CF260300060	K214109	000
M384CF260400030	K214109	000
06903195109043	K214109	000
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M384CF260700080	K214109	000
M384CF260800050	K214109	000
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M384CF260800090	K214109	000
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M384CF260800110	K214109	000
M384CF260800120	K214109	000
M384CF260800130	K214109	000
M384CF260800140	K214109	000
M384CF260800150	K214109	000
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M384CF260800040	K214109	000
M384CF260800030	K214109	000
M384CF260700090	K214109	000
M384CF260700100	K214109	000
M384CF260700110	K214109	000
M384CF260700120	K214109	000
M384CF260700130	K214109	000
M384CF260700140	K214109	000
M384CF260700150	K214109	000
M384CF260700160	K214109	000
M384CF260700170	K214109	000
M384CF260700180	K214109	000
M384CF260800010	K214109	000
M384CF260800020	K214109	000
M384CF260800170	K214109	000
M384CF260800180	K214109	000
M384CF260900010	K214109	000
M384CF260900170	K214109	000
M384CF260900180	K214109	000
06903195108459	K214109	000
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M384CF260900160	K214109	000
M384CF260900150	K214109	000
M384CF260900020	K214109	000
M384CF260900040	K214109	000
M384CF260900050	K214109	000
M384CF260900060	K214109	000
M384CF260900070	K214109	000
M384CF260900080	K214109	000
M384CF260900090	K214109	000
M384CF260900100	K214109	000
M384CF260900110	K214109	000
M384CF260900120	K214109	000
M384CF260900130	K214109	000
M384CF260900140	K214109	000
06903195109029	K214109	000