The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Uni-rom Total Hip System Femoral Stem.
| Device ID | K974331 |
| 510k Number | K974331 |
| Device Name: | UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1998-02-06 |
| Summary: | summary |