Changzhou Dingjian Medical Appliance Co L T D

FDA Filings

This page includes the latest FDA filings for Changzhou Dingjian Medical Appliance 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: 3011805173
• FEI Number: 3011805173
• Name: Cancan Huang
• Owner & Operator: Changzhou Dingjian Medical Appliance Co., Ltd.
• Contact Address: No. 19 Juxiang Road Wujin Economic Development Zone; Changzhou CN-32 Jiangsu 213149 CN
• Official Correspondent:
  • Qingsong Li
  • 086-519-88990051-x
• US Agent:
  • Cancan Huang
  • Osmunda Technology Co., Ltd.
  • 858 3571158
  • Sunny.Huang@osmundacn.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 949 White River Dr Allen, TX 75013 ; Allen, TX 75013 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K143013 | MNI Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN Spinal inner fixation	2015-12-14
PMN K143013 | MNI Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN II Spinal inner fixation	2015-12-14
PMN K143013 | MNI Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER Spinal inner fixation	2015-12-14
PMN K143013 | MNI Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER II Spinal inner fixation	2015-12-14
PMN K143013 | MNH Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN Spinal inner fixation	2015-12-14
PMN K143013 | MNH Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN II Spinal inner fixation	2015-12-14
PMN K143013 | MNH Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER Spinal inner fixation	2015-12-14
PMN K143013 | MNH Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER II Spinal inner fixation	2015-12-14
PMN K143013 | KWP Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN Spinal inner fixation	2015-12-14
PMN K143013 | KWP Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	VALEN II Spinal inner fixation	2015-12-14
PMN K143013 | KWP Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER Spinal inner fixation	2015-12-14
PMN K143013 | KWP Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	SIMER II Spinal inner fixation	2015-12-14
PMN K143013 Changzhou Dingjian Medical Appliance Co., Ltd	Spinal Inner Fixation System	2015-12-11
PMN K143002 | HWC Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	Metallic Locking Bone Plate and Screw System	2015-07-01
PMN K143002 | HRS Cancan Huang [Changzhou Dingjian Medical Appliance Co., Ltd.]	Metallic Locking Bone Plate and Screw System	2015-07-01
PMN K143002 Changzhou Dingjian Medical Appliance Co., Ltd	Metallic Locking Bone Plate And Screw System	2015-06-05