The following data is part of a premarket notification filed by Tianjin Walkman Biomaterial Co., Ltd. with the FDA for General Spinal System.
| Device ID | K140229 |
| 510k Number | K140229 |
| Device Name: | GENERAL SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-04-29 |
| Summary: | summary |