Kontour Xi An Medical Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Kontour Xi An Medical Technology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011423165
• FEI Number: 3011423165
• Name: KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.
• Owner & Operator: Kontour (Xi'an) Medical Technology Co., Ltd.
• Contact Address: Block 12, No.6, Qinling Avenue, Xi'an Hi ; Xi'an CN-14 Shanxi 710304 CN
• Official Correspondent:
  • rongrong cong
  • 86-029-63364685-x
• US Agent:
  • Adam Pannier
  • 310 8152100 1814
  • apannier@bioplate.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Block 12, No.6, Qinling Avenue, Xi'an High-tech Zone, Xi'an, Sha ; Xi'an Shanxi, 710304 CN
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 06903195107988 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020008	2022-11-30
GUDID 06903195107971 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020007	2022-11-30
GUDID 06903195107964 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020006	2022-11-30
GUDID 06903195107957 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020005	2022-11-30
GUDID 06903195107940 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020004	2022-11-30
GUDID 06903195107933 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020003	2022-11-30
GUDID 06903195107926 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020002	2022-11-30
GUDID 06903195107919 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26020001	2022-11-30
GUDID 06903195107902 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010018	2022-11-30
GUDID 06903195107896 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010017	2022-11-30
GUDID 06903195107889 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010016	2022-11-30
GUDID 06903195107872 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010015	2022-11-30
GUDID 06903195107865 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010014	2022-11-30
GUDID 06903195107858 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010013	2022-11-30
GUDID 06903195107841 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010012	2022-11-30
GUDID 06903195107834 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010011	2022-11-30
GUDID 06903195107827 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010010	2022-11-30
GUDID 06903195107810 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010009	2022-11-30
GUDID 06903195107803 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010008	2022-11-30
GUDID 06903195107797 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010007	2022-11-30
GUDID 06903195107780 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010006	2022-11-30
GUDID 06903195107773 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010005	2022-11-30
GUDID 06903195107766 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010004	2022-11-30
GUDID 06903195107759 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010003	2022-11-30
GUDID 06903195107742 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010002	2022-11-30
GUDID 06903195107735 Kontour(Xi'An) Medical Technology Co.,Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) CF26010001	2022-11-30
PMN K214109 Kontour(Xi’an) Medical Technology Co., Ltd.	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	2022-10-28
PMN K082757 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Modified Sterile Plate and Screw Configuration	2020-03-12
PMN K023810 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Modification to Bioplate Rigid Fixation System	2020-03-12
PMN K022890 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Modified Screw Design	2020-03-11
PMN K992330 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04
PMN K980983 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04
PMN K972463 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04
PMN K953273 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04
PMN K943071 | GXR KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Titanuim Fixation System	2020-03-04
PMN K022033 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Sterile Plate and Screw Configuration	2020-03-04
PMN K021684 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04
PMN K002426 | JEY KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Bioplate Rigid Fixation System	2020-03-04