The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. Mod Total Knee/condyl 3 Fem Comp Tib Insert.
| Device ID | K924340 |
| 510k Number | K924340 |
| Device Name: | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT |
| 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 | 1992-08-28 |
| Decision Date | 1994-01-25 |