The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Profemur Renaissance Hip Stem.
| Device ID | K051995 |
| 510k Number | K051995 |
| Device Name: | PROFEMUR RENAISSANCE HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Theresa Leister |
| Correspondent | Theresa Leister WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | JDL |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWA |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2005-08-22 |
| Summary: | summary |