The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c.(r) Modular Knee Syst, Stab All-plast Tibial.
Device ID | K910563 |
510k Number | K910563 |
Device Name: | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham, MA 02767 |
Contact | Marsha J Stone |
Correspondent | Marsha J Stone JOHNSON & JOHNSON ORTHOPAEDICS, INC. 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 | 1991-02-08 |
Decision Date | 1991-05-23 |