The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Tandry Locking Plate System.
| Device ID | K171904 |
| 510k Number | K171904 |
| Device Name: | Tandry Locking Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 407630 |
| Contact | Harrison Du |
| Correspondent | Harrison Du Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 407630 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2018-09-18 |
| Summary: | summary |