K191803 is an FDA 510(k) clearance for the Orthopedic Fixation Pin. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Tinavi (Anhui) Medical Technologies Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on April 14, 2020, 286 days after receiving the submission on July 3, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K191803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2019 |
| Decision Date | April 14, 2020 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW - Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |