The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for P.f.c. Modular Total Knee System, Modular Plus.
| Device ID | K923807 |
| 510k Number | K923807 |
| Device Name: | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL Raynham, MA 02767 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON INTERNATIONAL Raynham, MA 02767 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-29 |
| Decision Date | 1992-11-09 |