The following data is part of a premarket notification filed by Changzhou Dingjian Medical Appliance Co., Ltd with the FDA for Metallic Locking Bone Plate And Screw System.
| Device ID | K143002 |
| 510k Number | K143002 |
| Device Name: | Metallic Locking Bone Plate And Screw System |
| Classification | Plate, Fixation, Bone |
| Applicant | Changzhou Dingjian Medical Appliance Co., Ltd No.19 Juxiang Road, Wujin Economic Development Zone Changzhou, CN 213149 |
| Contact | Li Qingsong |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. 7th Floor Jingui Business Buildng No. 982 Cogyuan Rd BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-06-05 |
| Summary: | summary |