The following data is part of a premarket notification filed by Synthes (usa) Products Llc / Depuy Orthopaedics Inc. with the FDA for Depuy Synthes Sterilization Container System.
| Device ID | K181933 |
| 510k Number | K181933 |
| Device Name: | DePuy Synthes Sterilization Container System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Synthes (USA) Products LLC / DePuy Orthopaedics Inc. 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Thomas Shea |
| Correspondent | Thomas Shea Synthes (USA) Products LLC / DePuy Orthopaedics Inc. 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-19 |
| Decision Date | 2019-05-09 |