The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Plus Total Knee System, Poly Patellar Button.
| Device ID | K872134 |
| 510k Number | K872134 |
| Device Name: | PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-03 |
| Decision Date | 1987-10-14 |