The following data is part of a premarket notification filed by Tianjin Walkman Biomaterial Co., Ltd. with the FDA for Metallic Intramedullary Nail System.
| Device ID | K132078 |
| 510k Number | K132078 |
| Device Name: | METALLIC INTRAMEDULLARY NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | TIANJIN WALKMAN BIOMATERIAL CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong TIANJIN WALKMAN BIOMATERIAL CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2014-03-19 |
| Summary: | summary |