The following data is part of a premarket notification filed by Weigao Orthopaedic Device Co., Ltd with the FDA for Intramedullary Nail System.
| Device ID | K122994 |
| 510k Number | K122994 |
| Device Name: | INTRAMEDULLARY NAIL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | WEIGAO ORTHOPAEDIC DEVICE CO., LTD PO BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIGAO ORTHOPAEDIC DEVICE CO., LTD PO BOX 237-023 Shanghai, CN 200237 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-04-12 |
| Summary: | summary |