The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Mg Ii Porous Cobal T-chrome Femoral Component.
| Device ID | K911572 |
| 510k Number | K911572 |
| Device Name: | MG II POROUS COBAL T-CHROME FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-07-01 |