K162124 is an FDA 510(k) clearance for the Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins. This device is classified as a Condylar Plate Fixation Implant (Class II - Special Controls, product code JDP).
Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on March 29, 2017, 240 days after receiving the submission on August 1, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K162124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2016 |
| Decision Date | March 29, 2017 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDP - Condylar Plate Fixation Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |