The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for J-fx Bipolar Head.
| Device ID | K980801 |
| 510k Number | K980801 |
| Device Name: | J-FX BIPOLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-05-29 |
| Summary: | summary |