The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Tricon-m Total Knee System.
| Device ID | K884824 |
| 510k Number | K884824 |
| Device Name: | TRICON-M TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Stephen M Doyle |
| Correspondent | Stephen M Doyle RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBV |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-11-21 |