The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. 2 Total Hip System Porous Coated Modular Femoral Component.
| Device ID | K945518 |
| 510k Number | K945518 |
| Device Name: | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | J T Dorriety |
| Correspondent | J T Dorriety JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1996-03-08 |
| Summary: | summary |