K171904 is an FDA 510(k) clearance for the Tandry Locking Plate System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Microware Precision Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on September 18, 2018, 449 days after receiving the submission on June 26, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K171904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2017 |
| Decision Date | September 18, 2018 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS - Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |