The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Hip System Porous Coated Femoral Component.
| Device ID | K893872 |
| 510k Number | K893872 |
| Device Name: | P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha Stone |
| Correspondent | Marsha Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-26 |
| Decision Date | 1989-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295207641 | K893872 | 000 |
| 10603295207634 | K893872 | 000 |
| 10603295207627 | K893872 | 000 |
| 10603295207610 | K893872 | 000 |
| 10603295207603 | K893872 | 000 |
| 10603295207597 | K893872 | 000 |