K191617 is an FDA 510(k) clearance for the Syntec Tibial Nail System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Syntec Scientific Corporation (Chang Hua, TW). The FDA issued a Cleared decision on September 3, 2019, 77 days after receiving the submission on June 18, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K191617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2019 |
| Decision Date | September 03, 2019 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |