The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Profemur Gladiator Ha Hip Stem.
| Device ID | K112150 |
| 510k Number | K112150 |
| Device Name: | PROFEMUR GLADIATOR HA HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Matt Paul |
| Correspondent | Matt Paul WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KWA |
| Subsequent Product Code | JDL |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-27 |
| Decision Date | 2011-11-23 |
| Summary: | summary |