The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Plus Total Knee Syst/peri Post Design Tibial Comp.
| Device ID | K901936 |
| 510k Number | K901936 |
| Device Name: | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-07-03 |