The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Tibial Tray Pmma Plug For Plus/axiom Total Knee Sy.
| Device ID | K911198 |
| 510k Number | K911198 |
| Device Name: | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1991-05-23 |