The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Tricon M Tibial Component.
| Device ID | K843242 | 
| 510k Number | K843242 | 
| Device Name: | TRICON M TIBIAL COMPONENT | 
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer | 
| Applicant | RICHARDS MEDICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | JWH | 
| CFR Regulation Number | 888.3560 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-08-07 | 
| Decision Date | 1984-09-26 |