The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Summit Hip System.
| Device ID | K170339 |
| 510k Number | K170339 |
| Device Name: | Summit Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Carol S. Ming |
| Correspondent | Daniel J. Williman DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-02 |
| Decision Date | 2018-04-26 |