Synthes USA Products, LLC · Class II · Cleared Feb 16, 2017
| K-number | K161616 |
| Device name | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw |
| Applicant | Synthes USA Products, LLC |
| Product code | HWC |
| Device class | Class II |
| Decision date | Feb 16, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
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