The following data is part of a premarket notification filed by Synthes (usa) Products Llc/depuy Orthopaedics Inc with the FDA for Depuy Synthes (usa) 5.0mm / 7.3mm Crimp Positioning Pins – Mr Conditional, Depuy Synthes Variable Angle Positioning Pins – Mr Conditional, Depuy Synthes Wire Mount – Mr Conditional, Depuy Synthes Cerclage Positioning Pin – Mr Conditional.
| Device ID | K172975 |
| 510k Number | K172975 |
| Device Name: | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional |
| Classification | Cerclage, Fixation |
| Applicant | Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Suchitra Basu |
| Correspondent | Suchitra Basu Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-06-21 |
| Summary: | summary |