The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c.(tm) Modular Knee System.
| Device ID | K884796 |
| 510k Number | K884796 |
| Device Name: | P.F.C.(TM) MODULAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-16 |
| Decision Date | 1989-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295251767 | K884796 | 000 |
| 10603295232698 | K884796 | 000 |
| 10603295232681 | K884796 | 000 |
| 10603295232667 | K884796 | 000 |
| 10603295232650 | K884796 | 000 |
| 10603295065005 | K884796 | 000 |
| 10603295064992 | K884796 | 000 |
| 10603295064985 | K884796 | 000 |
| 10603295064978 | K884796 | 000 |
| 10603295064961 | K884796 | 000 |
| 10603295064954 | K884796 | 000 |
| 10603295064947 | K884796 | 000 |
| 10603295215486 | K884796 | 000 |
| 10603295251736 | K884796 | 000 |
| 10603295251750 | K884796 | 000 |
| 10603295251743 | K884796 | 000 |
| 10603295251729 | K884796 | 000 |
| 10603295251712 | K884796 | 000 |
| 10603295216834 | K884796 | 000 |
| 10603295216810 | K884796 | 000 |
| 10603295216803 | K884796 | 000 |
| 10603295215479 | K884796 | 000 |
| 10603295215462 | K884796 | 000 |
| 10603295215455 | K884796 | 000 |
| 10603295215448 | K884796 | 000 |
| 10603295215431 | K884796 | 000 |
| 10603295064930 | K884796 | 000 |