The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Mg Ii Porous Total Knee System.
Device ID | K892800 |
510k Number | K892800 |
Device Name: | MG II POROUS TOTAL KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | William Christianson |
Correspondent | William Christianson 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 | 1989-04-17 |
Decision Date | 1989-08-03 |