The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Cemented Calcar Replacement Femoral Stem.
| Device ID | K964795 |
| 510k Number | K964795 |
| Device Name: | CEMENTED CALCAR REPLACEMENT FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Deana M Boushell |
| Correspondent | Deana M Boushell JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-02-19 |
| Summary: | summary |