The following data is part of a premarket notification filed by Tinavi (anhui) Medical Technologies Co., Ltd. with the FDA for Orthopedic Fixation Pin.
| Device ID | K191803 |
| 510k Number | K191803 |
| Device Name: | Orthopedic Fixation Pin |
| Classification | Pin, Fixation, Threaded |
| Applicant | Tinavi (Anhui) Medical Technologies Co., Ltd. Building 5,Robot Industrial Base Of TusCity, Jinxiu Avenue/Susong Road, Hefei, CN 230601 |
| Contact | Jianhua Jiang |
| Correspondent | Jianhua Jiang Tinavi (Anhui) Medical Technologies Co., Ltd. Building 5,Robot Industrial Base Of TusCity, Jinxiu Avenue/Susong Road, Hefei, CN 230601 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2020-04-14 |