The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Summit Basic Press-fit Hip Stem.
| Device ID | K030122 |
| 510k Number | K030122 |
| Device Name: | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-14 |
| Decision Date | 2003-02-05 |
| Summary: | summary |