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 |