The following data is part of a premarket notification filed by Canwell Medical Co., Ltd with the FDA for Metallic Locking Bone Plate And Screw.
| Device ID | K142943 |
| 510k Number | K142943 |
| Device Name: | Metallic Locking Bone Plate And Screw |
| Classification | Plate, Fixation, Bone |
| Applicant | Canwell Medical Co., Ltd No.329 Yongkang Street Jinhua, CN 321015 |
| Contact | Chen Hui |
| 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 | 2014-10-10 |
| Decision Date | 2015-08-03 |
| Summary: | summary |