The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Mg Ii Total Knee System Stemmed Tibial Baseplate Components.
| Device ID | K050723 |
| 510k Number | K050723 |
| Device Name: | MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Contact | Toni Kingsley |
| Correspondent | Toni Kingsley ZIMMER, INC. 345 E. MAIN ST. Warsaw, IN 46580 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-04-20 |
| Summary: | summary |